MPR Weekly Dose: Recent Episodes
MPR Weekly Dose
Each week the MPR team brings you the top stories from the world of medicine and pharma in a matter of minutes. With 35 years of publishing drug information behind us, you can rely on MPR to provide accurate and up-to-date news.
Moderna's mRNA influenza vaccine gains FDA approval; approvals for prostate cancer, narcolepsy type 1 and Mucinex 12HR; and peanut allergy treatment gains Fast Track status.
An over-the-counter acetaminophen/naproxen sodium fixed-dose tablet gains approval; Simtriyo approved for ADHD; Xocova approved for COVID-19 postexposure prophylaxis; A new contraceptive patch is approved; and Furoscix ReadyFlow approval is expanded to treat edema in CHF, CKD.
Kalshi start clinical trials, FDA approvals prediction market; positive results shared for triple hormone therapy retatrutide; Jideytro gains approval in advanced or metastatic ROS1-positive NSCLC; a smart toilet seat hits the market to measure your vitals; and the FDA accepts an application for pretreated metastatic pancreatic cancer treatment, daraxonrasib.
The latest on the multistate cyclospora outbreak; Lipfendra approved to reduce low-density lipoprotein cholesterol in adults with hypercholesterolemia; subcutaneous starting dose regimen approved for Leqembi; NDA accepted for oral sleep apnea treatment; and Revtorpyk combination approved for advanced breast cancer.
A new treatment is approved to reduce proteinuria in adults with primary immunoglobulin A nephropahty; a swimmer's ear treatment and the thyroid hormone replacement therapy Amerithroid are now available; Casgevy approval expanded include pediatrics; and a lupus treatment is granted breakthrough status.
A single, once-weekly tablet could change HIV treatment landscape; weight loss drug orforglipron efficacy assessed at all stages of menopause; hemophilia treatment Hympavzi gains expanded indication; and the FDA adds a warning label for kidney injury to an over-the-counter weight loss aid.
New treatment approved for adults with complicated urinary tract infections; Xocova approved for COVID-19 postexposure prophylaxis; investigational diabetic macular edema eye drop fails to meet trial endpoint; Afrezza expanded for pediatric use; obefazimod looks promising for ulcerative colitis.
New triple hormone receptor agonist shows significant weight loss; hepatitis delta virus treatment gains accelerated approval; acne gel gains OTC designation; constipation treatment expanded to include younger patients; and the FDA extends review for camizestrant in advanced breast cancer.
US News and World Report releases their annual best over-the-counter products list; new guidance for drug safety evaluation during pregnancy; gMG indication broadened for efgartigimod; Beqalzi gains accelerated approval for MCL; and a novel treatment fast tracked for ALS.
Ozempic tablets are now available; investigational ALS treatment gains FDA Fast Track status; positive results for aficamten in non-obstructive hypertrophic cardiomyopathy; motion sickness drug Nereus now available; Lantus alternative Langlara gains approval.
Gene therapy approved to restore hereditary hearing loss; investigational treatment shows hair coverage improvements in male pattern loss; Breztri approved as a maintenance treatment for asthma; gene editing candidate meets endpoints in hereditary angioedema trial; novel dual glucagon/GLP-1 receptor agonist demonstrates significant weight loss.
Two-drug, single-tablet approved to replace current antiretroviral regimen; Dupixent approved for pediatric CSU; novel treatment significantly improves survival in metastatic pancreatic cancer; oral semaglutide for adolescents; GLP-1 Fast Tracked for knee osteoarthritis.
Foundayo, an oral GLP-1, now available for weight loss; results from the ACHIEVE-4 trial; Filspari gains approval for FSGS; a new formulation of amlodipine, and the FDA signals support for broader use of testosterone replacement therapy.
High-dose Wegovy now available for additional weight reduction when clinically indicated; trial results for durvalumab combo treatment in patients with unresectable hepatocellular; generic dapagliflozin gets green light, paving the way for generic manufacturers; achondroplasia treatment Yuviwel now available.
Lifyorli combo approved for ovarian cancer; mixed results from Lyme disease vaccine trial; treatment approved for rare Hunter syndrome and Awiqli gets approval as once-weekly basal insulin for type 2 diabetes.
A federal court blocks changes to the childhood immunization schedule by the recently appointed vaccine advisory committee; higher dose Wegovy injection gets green light; Cosentyx expanded to include pediatric hidradenitis suppurativa; investigative triple hormone therapy shows significant weight reduction in diabetes.
Sotyktu's approval expanded to encompass active psoriatic arthritis; the FDA approves leucovorin for rare disorder, not autism; safety concerns prompt Tazverik withdrawal; FDA to review potential new hypertension treatment.
Glenmark to launch the first generic version of Flovent HFA, expanding affordable access; achondroplasia treatment granted accelerated approval; Dupixent approved for allergic fungal rhinosinusitis; and a swallowable balloon offers a unique outpatient alternative for weight management.
We explore the FDA's expansion of Wakix as the first non-scheduled treatment for pediatric cataplexy; a Taltz and Zepbound combo shows promise in skin clearance for patients with psoriasis and obesity; we also look at the frontier of mental health with synthetic psilocybin; there's phase 3 results from a potential new treatment for chronic inducible hives; and a long-acting HIV injection could be a game-changer for patients who struggle with the daily pill grind.
Recent medical updates highlight the long-term health benefits of the universal hepatitis B birth dose, alongside FDA milestones including the approval of Optune Pax for pancreatic cancer and a pembrolizumab-based regimen for platinum-resistant ovarian cancer, and the granting of priority review to oveporexton for narcolepsy type 1.
Combo treatment aims to be latest to enter the weight loss space; Amgen refuses to remove drug from market despite FDA request; Novo Nordisk threatens legal action against Hims & Hers; an oral film formulation of sildenafil is approved; and the FDA accepts the NDA for zanzalintinib plus atezolizumab for metastatic colorectal cancer.
AAP maintains routine vaccine recs despite CDC changes; FDA warns of serious injury with wound and burn products; subcutaneous Alzheimer disease treatment under review; Cardamyst nasal spray available; and the FDA places clinical hold on 2 gene therapies.
New research on acetaminophen use during pregnancy; the chikungunya vaccine Ixchiq is withdrawn; FDA approves Nexplanon for up to 5 years of use; suicidal ideation warning removed from GLP-1s; at-home neuromodulation therapy cleared for adults with major depressive disorder.
Fifty-eight health experts have weighed in on the future of wellness. In this episode, we sit down with Annika Urban, health editor for US News and World Report, to analyze the implications of these findings. Annika shares her perspective on the major shifts happening across the health spectrum.
ACIP votes to change hep B vaccination for infants; positive results for retatrutide; Omisirge approved; counterfeit Ozempic seized by FDA; gene therapy approved for Wiskott-Aldrich syndrome.
Jaypirca gains expanded approval; allograft approved to restore peripheral nerve function; baxdrostat to be reviewed as an add-on treatment for hypertension; treatment for a genetic eye disorder that causes vision loss shows promise; and an autoinjector to treat edema is accepted for Priority Review.
Tonmya now available for fibromyalgia; safety warnings for DMD treatment; mitapivat shows mixed results in sickle cell disease trial; Redemplo approved for familial chylomicronemia syndrome; Hyrnuo approved for HER2-mutant NSCLC.
The FDA requests boxed warnings be removed from HRT product labels; Caplyta approved for MDD; Darzalex Faspro gains new indication; investigational MS treatment looks promising; trial investigates simplified HIV regimen.
FDA restrict the sale of unapproved fluoride products; the AAP statement on leucovorin in ASD; at-home prenatal ultrasound; Kygevvi approved; Gazyva reduces SLE disease activity.
Label changes for tranexamic acid; new approval for Tezspire; psychedelic gains Breakthrough Tx for depression; oral semaglutide approved to reduce MACE risk in T2DM; Gazyva approved for lupus.
New treatment approved for Bipolar I disorder; IBD treatments gain expanded approval; blood-based test for early detection of Alzheimer disease; and an oral glucagon-like peptide-1 treatment continues to show promise.
CDC approves new immunization schedule; new treatments approved for edema, idiopathic pulmonary fibrosis, and high risk cutaneous squamous cell carcinoma; and the FDA grants Breakthrough therapy designation to a novel influenza therapy.
New treatment approved for primary humoral immunodeficiency; eyedrops now available to improve near vision; Tremfya approval expanded to include pediatric plaque psoriasis, psoriatic arthritis; FDA fast tracks treatments for methamphetamine intoxication, Alzheimer disease.
The CDC recommends changes to MMRV vaccine use; Trump administration claims acetaminophen linked to autism; first Barth syndrome treatment gets green light; gene therapy looks promising for Huntington disease; and a new SC formulation of Keytruda gains approval.
New device approved to prevent intrauterine adhesions; oral GLP-1 receptor agonists assessed in head to head trial; nasal spray formulation of bumetanide gains approval; Capvaxive elicits immune response in children aged 2 to 17 years; and a primary biliary cholangitis treatment is withdrawn from the market.
COVID-19 vaccine approvals; CDC leadership in turmoil; orforglipron weight loss trial results; Ixchiq license suspended by FDA; REMS updated for Filspari
COVID-19 vaccine approvals; CDC leadership in turmoil; orforglipron weight loss trial results; Ixchiq license suspended by FDA; REMS updated for Filspari
The American Academy of Pediatrics release their own immunization schedule; The American Heart Association update 2017 guidelines for the prevention of high blood pressure; weight loss drug gains indication to treat noncirrhotic MASH; FDA approve a new fibromyalgia treatment; investigational SCD Tx to meet trial endpoint.
Nerve stimulation device cleared for sleep apnea; Skysona safety update; new non-cystic fibrosis bronchiectasis treatment; FDA cracks down on animal-derived thyroid meds; RSV therapy to be discontinued.
Class-wide label change for opioids; positive results for oral GLP-1; migraine prevention therapy approved for children; FDA removes restriction on Ixchiq for older adults; Modeyso approved for rare brain tumor.
Empaveli approved to treat two rare kidney diseases; Elevidys available again for ambulatory patients; Mounjaro shows benefit in cardiovascular disease; wearable cardiac monitor gets clearance; upadacitinib trial shows hair regrowth in individuals with alopecia areata.
Elevidys shipments paused following third death; FDA committee votes against brexpiprazole combo for PTSD; Rapiblyk now available for SVT; sleep apnea pill looks promising; JUUL e-cigarettes gain marketing authorization.
New indication for Kerendia; investigational therapy shows promise for hypertension; Novolog interchangeable biosimilar gets approval; trial results for hormone-free contraceptive; Shingrix now supplied in a prefilled syringe.
Lawsuit filed against RFK Jr over vaccine policy changes; oral on-demand treatment approved for HAE; OTC cuffless blood pressure monitor gets greenlit; dosing schedule update for Alzheimer treatment; REMS requirement removed for endothelin receptor antagonist meds.
Wristband that provides relief for upper limb tremor is approved; FDA warns of clinically significant weight loss in younger kids taking ADHD meds; REMS removed for CAR T-cell immunotherapies; treatment approved for lung cancer patients with EGFR exon20 insertion mutations; and CDC committee recommends removing preservative from flu vaccines.
Novo Nordisk end their partnership with Hims & Hers; update to Vizamyl labeling; autoinjector approved for pediatrics with lupus nephritis; psilocybin shows promise in treatment-resistant depression; sotatercept phase 3 trial results.
Nucala gains new indication; the FDA are set to require placebo-controlled trials to evaluate COVID-19 vaccines; pruritus reported following discontinuation of antihistamines; oral carbapenem antibiotic looks promising for cUTIs; investigational celiac disease Tx gets Fast Tracked
At-home cervical cancer screening device gains clearance; the FDA indicates it wants to remove pediatric fluoride products from the market; the chikungunya vaccine is put on-pause for some individuals; a subcutaneous autoinjector is approved to treat migraines; and the FDA will review a gene therapy for Hunter syndrome.
A new epinephrine nasal spray dosage has been approved for pediatrics; FDA agree to review Semaglutide for weight management; A wearable defibrillator is cleared to prevent sudden cardiac arrest; a low dose formulation of chlorthalidone is approved to treat hypertension; and Selarsdi is now interchangeable with Stelara.
Rinvoq approved for giant cell arteritis; telehealth companies collaborate with Novo Nordisk for Wegovy access; epidermolysis bullosa wound healing treatment approved; Imaavy approved for gMG; New nasal powder approved for migraine treatment.
The FDA issues alert regarding a compounded topical finasteride; plant-based alkaloid shows improvement for smoking cessations; potential new treatment option for GERD; and the CDC’s Advisory Committee on Immunization Practices make new recommendations.
Pfizer ends danuglipron clinical program for obesity; FDA warns about counterfeit Ozempic; daily pill shows promise in reducing HbA1c; mavacamten misses in nonobstructive HCM trial and the FDA clears smart belt device reduce fall injury.
Uplizna gains new indication; Vanrafia approved for proteinuria in IgAN; Erzofri now available for schizophrenia; setmelanotide shows promise in hypothalamic obesity; GLP-1RAs may reduce dementia risk.
New treatments for Prader-Willi Syndrome and hemophilia; FDA fast tracks a chlamydia vaccine candidate; over-the-counter test cleared for identifying chlamydia, gonorrhea and trichomoniasis; semaglutide improves walking ability in patients with peripheral artery disease; and Imfinzi combo therapy approved for MIBC.
New antibiotic has been approved for uncomplicated UTIs; Cabometyx approved for advanced neuroendocrine tumors; new rosacea treatment option; Tremfya gains Crohn disease indication; Department of HHS cuts 10,000 jobs.
Influenza vaccine recommendations made for upcoming season; a patient dies following Elevidys infusion; Chikungunya vaccine now available and recommended for those traveling to areas with an outbreak; novel Alzheimer disease treatment launches; risk evaluation and mitigation strategies removed for hypertension treatment.
First Xolair biosimilar approved, Wearable furosemide loop diuretic gains expanded indication; Implant approved for macular telangiectasia; Novel treatment shows promise in hypertension; And testing reveals high benzene levels in over-the-counter acne treatments.
Labeling changes for testosterone products; food allergy treatments compared; FDA approves stroke Tx; COVID-19, flu vaccine effectiveness for recent season; Neffy 1mg approved
REMS requirement removed for schizophrenia treatment; new copper intrauterine device approved; Wegovy, Ozempic no longer in short supply; stem cell therapy for chronic lumbar disc disease fast tracked; ecopipam shows promise for Tourette syndrome.
New vaccines to protect against meningococcal disease and chikungunya virus; skin prep product recalled due to fungal contamination; rapid-acting insulin biosimilar approved; and twice-yearly lenacapavir gets FDA's priority review for HIV PrEP.
Study identifies potential treatment strategy for high-threshold peanut allergy; Emblaveo approved for complicated intra-abdominal infections; new tablet formulation of Evrysdi; FDA fast tracks investigational agents for Alzheimer disease and cannabis use disorder.
FDA say there are reports that diabetes patients are missing critical safety data from their smartphone devices; A wearable continuous apomorphine infusion device has been approved for Parkinson disease ‘off’ periods; New migraine and pain treatments get the green light; And a study suggest propranolol may cut stroke risk in certain patients.
Ozempic gains expanded approval; MS treatment gets Boxed Warning added to label; Monotherapy approval granted for treatment resistant depression Tx Spravato; Leqembi gains maintenance regimen; Enhertu gains new Breast CA indication.
The FDA has issued a proposal to remove a common decongestant in over the counter products; A follow-up study assesses the efficacy of a schizophrenia treatment; The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee panel takes vote on the potential of approving a new diabetes treatment; IV ibuprofen adverse reactions examined; And semaglutide found to improve liver fibrosis.
Libby Baney, Senior Advisor to ASOP Global and a partner at Faegre Drinker Consulting, talks to MPR about the current state of online pharmacies and what is being done to protect patients.
Supplies of a significant number of IV solutions have been impacted by Hurricane Helene; First at-home COVID-19/Flu over-the-counter antigen test gains market authorization; DOJ clamp down on fake online pharmacies; Investigational therapy Fast Tracked for treatment resistant depression; and Cologuard Plus gets cleared for colorectal cancer screening.
The FDA clears capsule that creates sensation of fullness in the stomach; Complete Response Letter issued for gastroparesis treatment; Apple’s sleep apnea notification feature gets clearance; Keytruda gains malignant pleural mesothelioma indication; Ebglyss approved for atopic dermatitis
New drug approved to treat ulcerative colitis; Once-weekly insulin efsitora investigated in type 1 diabetes; Dupilumab shows efficacy for treating urticaria; A twice-yearly injection shows potential for treating severe asthma; and GSK calls an end to their development of a herpes vaccine.
CDC Advisory Committee issue vaccine guidelines for flu season; Smallpox vaccine gains expanded indication; Updated Novavax COVID-19 vaccine; Over-the-counter gel for erectile dysfunction; New inserter system for placement of contraceptive intrauterine system.
Genentech decide to remove Fuzeon from US market; Rybrevant and Lazcluze approved as first-line treatment for certain patients with EGFR-mutated advanced NSCLC; FDA warning regarding unapproved potassium phosphates; Otezla approval expanded to include treatment of pediatric patients; Results from tirzepatide diabetes risk reduction study.
New Treatment for Primary Biliary Cholangitis; Nemluvio approved for prurigo nodularis; FDA Denies MDMA for PTSD; New hypoparathyroidism treatment; First digital therapeutic approved for depression.
The FDA give an updated on the availability of obesity drugs; The CDC has issued an updated guideline on contraceptive use; The first T-cell gene therapy is approved for synovial sarcoma; Lymphir gains approval for relapsed or refractory cutaneous T-cell lymphoma; Fabhalta gains a new indication.
FDA voice concerns over compounded semaglutide; New treatment approved for mild to moderate dementia of the Alzheimer type; Colorectal cancer screening test gets green light; Leqselvi approved for alopecia; And peanut allergy treatment gains expanded indication.
Duchenne muscular dystrophy treatment now available; Noise therapy wearable for nasal congestion; Treatment for delaying diabetes gets Fast Tracked; Soliris biosimilar approved; And the first orally-disintegrating contraceptive.
Seizure medication recalled due to wrong strength on carton; Gene therapy gains Fast Track status for Parkinson disease; Dendritic cell vaccine being developed for pancreatic cancer; Generic version of sickle cell disease treatment Endari is made available
New steroid-free topical for atopic dermatitis; A refillable ocular implant for the treatment of neovascular (wet) age-related macular degeneration returns following recall; A neuroimmune modulation device shows clinical benefit in adults with rheumatoid arthritis; FDA denies Novo Nordisk’s once-weekly insulin icodec; And a smarthphone therapy shows benefit for patients with fibromyalgia.
New maintenance treatment approved for COPD; Authorized generic version of Victoza launches; Duchenne muscular dystrophy treatment indication expanded; Narcolepsy treatment expanded for certain pediatric patients; FDA clears digital therapeutic for ADHD.
Skyrizi has been approved for ulcerative colitis; New pneumococcal vaccine approved; An indictment may impact as much as 50,000 patients who need ADHD meds; Results announced for Moderna’s next-gen COVID-19 vaccine; Farxiga approval expanded.
Two glucose monitoring systems have been cleared for over-the-counter sale; Arexvy gains approval for adults aged 50 to 59 years; Kevzara approved for active polyarticular juvenile idiopathic arthritis; Generic Duchenne muscular dystrophy drug is made available; and Iqirvo gets accelerated approval for primary biliary cholangitis.
First generics of heart failure drug gain approval; mRNA vaccine approved for RSV; CDC make drug recommendation for STI prevention; Advisory Committee vote on MDMA for PTSD; Rinvoq approval expanded
Extended-release ADHD treatment gains approval; An interchangeable biosimilar to Soliris is approved; Investigational treatment shows promise for improving depression and insomnia; The FDA vote on a blood-based colorectal cancer diagnostic; Survey reveals public attitudes towards the FDA.
Self-administered device cleared to treat stress urinary incontinence in women; Autoinjector warning for relapsing MS treatment; COVID-19 preexposure prophylaxis investigational treatment looks promising; Biosimilars for Eylea approved; Imdelltra approved for extensive stage small cell lung cancer with disease progression.
Reliability of COVID-19 tests unreliable; Insulin pump app updated following battery issue; Noninvasive colorectal cancer test gets FDA approval; Self-collection HPV screening option; National Drug Threat Assessment highlights illicit drugs currently endangering the US.
Dr. Michael Ganio, ASHP's Director of Pharmacy Practice and Quality, joins me to discuss the current drug shortage crisis, which has reached new levels.
Dr Charles Raison, the Director of Clinical Research at the Usona Institute and Professor in the Department of Psychiatry at the University of Wisconsin–Madison, joins me to discuss the potential of psilocybin as a therapy for major depressive disorder.
Asthma treatment gains approval for severe cases in pediatrics; Dovato gains expanded indication; Decision taken to remove ALS drug from market; Complete Response Letter issued for apomorphine device; At-home Mpox test kit made available.
First prescription smartphone app approved for major depressive disorder; Novel blood test to detect TBI; Zevtera approved for bloodstream infections; Mpox vaccine is now commercially available; Algorithm cleared for LVEF dectection.
Preexposure prophylaxis approved for COVID-19; Nexletol and Nexlizet gain expanded approval; Novel Duchenne muscular dystrophy treatment; First blood test to screen for malaria in donors; Warning letter for OTC topical analgesic products.
Nasal spray approved for chronic rhinosinusitis; Endothelin receptor antagonist gains approval to lower blood pressure in hypertension; One-time stem cell treatment approved for metachromatic leukodystrophy; NASH treatment gains accelerated approval; New automated insulin delivery system for type 1 diabetes.
Weight loss treatment has approval expanded; Paxlovid with Emergency Use Authorized label must be disposed of; psychedelic gets Breakthrough therapy designation; Advisory Committee announce meeting to discuss Alzheimer treatment; ALS treatment trial results
Over-the-counter birth control pill to be available in the coming weeks; first over-the-counter continuous glucose monitor to be available starting this summer; the 2024-2025 US influenza season vaccine will be trivalent; LSD granted Breakthrough Therapy for treatment of generalized anxiety disorder; interchangeable biosimilars to Prolia and Xgeva approved.
FDA withdraw multiple myeloma treatment after a confirmatory trial showed an increased risk of death; latest efficacy results for lower respiratory tract disease vaccine; CDC Chikungunya virus vaccine recommendations; Complete Response Letter issued to investigative schizophrenia treatment; new treatment for complicated UTIs including pyelonephritis; over-the-counter eye ointments recalled.
First treatment approved to reduce allergic reactions in those with multiple food allergies; T-cell therapy given accelerated approval to treat unresectable or metastatic melanoma; Vit D supplement recalled due to superpotency; cannabidiol may help resolve the symptoms of pericarditis; FDA warn against certain wearables that claim to measure blood glucose.
FDA approves first treatment for severe frostbite; Eohilia gains approval to treat eosinophilic esophagitis; MDMA accepted for Priority Review for PTSD; novel subcutaneous to be reviewed for prurigo nodularis, atopic dermatitis; OTC pulse oximeter device is cleared.
Combination intravenous formulation of acetaminophen and ibuprofen approved; recommendations from the ADA for dealing with acute dental pain; RSV vaccine under review for younger adult age group; Gilead call halt on investigational leukemia treatment hagrolimab; athlete foot spray recalled.
Biogen discontinue Alzheimer treatment; The American Academy of Dermatology issue new acne vulgaris management guidelines; Update for ongoing availability of Paxlovid; Narcolepsy/ADHD treatment recalled for containing wrong drug; FDA warn against copycat eye drop products
T-cell malignancies prompt label changes for certain T-cell immunotherapies; Novel opioid provides in-built protection against overdose; Hypocalcemia risk with Prolia; At-Home semen insemination kit cleared; New asthma rescued medicine approved
Gene therapy approved for beta thalassemia; treatment for preventing of chronic inflammatory demyelinating polyneuropathy relapse; device to aid dermatologist referrals; vertebral strength device for low-bone mass; Narcan shelf-life extension
Researchers examine link between diabetes, obesity treatments and suicidal ideation; topical treatment for molluscum contagiosum; IV bags recalled following discovery that they may contain twice as much of the labeled drug; update on the penicillin shortage; newly cleared test measures HbA1c from menstrual blood.
An expert panel rank the 30 best diets for 2024; Counterfeit Ozempic on the rise; Myasthenia gravis drug approved; Herpes tests may produce false positives; Safety concerns over IV promethazine hydrochloride.
Topical gel approved to treat partial thickness wounds in epidermolysis bullosa; Priority Review given to 21-valent pneumococcal conjugate vaccine; sensory and motor stimuli video game for ADHD gains expanded age approval; on-demand HIV prevention for women; multiple food allergy drug
The ADA release their new guidance for the management of diabetes 2024; a new blood collection device obtains lab-quality samples using a the finger; novel treatment for postpartum depression becomes available; a study for a male birth control pill begins; and a Public Benefit Corporation seeks approval for an MDMA-assisted therapy.
Novel weight loss treatment now available in pharmacies; Novo Nordisk warns about the risks of compounded semaglutide; treatment approved for paroxysmal nocturnal hemoglobinuria; over-the-counter insemination kit cleared by the FDA.
Safety alert issued for serious reactions to certain seizure drugs; Drug approved to treat a rare form of tumor; T-cell malignancies reported with cell immunotherapies; organ transplant rejection treatment recalled; CPAP machine associated with reports of burns and fires.
First chikungunya vaccine approved; FDA send warning letter to Amazon about ophthalmic products; at-home STD test cleared; Bayer withdraw lymphoma drug; and a combo treatment to reduce catheter-related bloodstream infections is approved.
New weight management approved; Novo Nordisk discontinue Levemir; adjunctive system for hypertension patients; frontotemporal dementia treatment given Fast Track designation; and the FDA advise against use of glucose supplement.
FDA urge immediate discontinuation for eye drop products; safety alert issued for the pediatric Moderna COVID-19 vaccine; novel heartburn medicine approved; Stelara biosimilar approved; and an antibody to prevent fentanyl overdose gets fast tracked.
New pentavalent meningococcal vaccine approved; Gohibic’s shelf-life extended by 6 months; maintenance treatment approved for adults with moderately to severely active ulcerative colitis or Crohn disease; self-administered option for FluMist Quadrivalent accepted for review; intravenous combo formulation of acetaminophen and ibuprofen approved for postoperative pain.
FDA approves a novel treatment for major depressive disorder; vote taken on stem cell therapy for ALS; preservation-free Iyuzeh now available; CDC recommends RSV vaccine for during pregnancy; investigational treatment shows promise in familial chylomicronemia syndrome.
Bacterial pneumonia treatment now available; FDA deny proposed anaphylaxis treatment; Results on flu vaccine efficacy; More flexible dosing for Talicia; Change in the therapeutic equivalence for organ rejection drug generic.
The FDA and CDC greenlight updated COVID-19; prescription drug for dry eye disease now available; head-to-head study comparing Skyrizi to Stelara for Crohn disease; the REMS program has been updated for IBS treatment Lotronex; and the FDA cracks down on companies selling unnaproved eye products.
With fall on the horizon, MPR sat down with Assistant Professor of Clinical Pharmacy at the University of California San Diego, Dr. Abdul-Mutakabbir. Our wide ranging talk covers the updated COVID-19, flu and RSV vaccines. We also discuss vaccine hesitancy, health equity and representation in medicine.
New vaccine guidelines issued for the 2023-2024 flu season; USPSTF make recommendations on PrEP prescribing; maternal RSV vaccine; updated COVID vaccine shows strong immune response; new treatment approved for rare immune disease.
FDA issue recommendations to avoid Company's tests; RSV vaccine now available for older adults; New treatments approved for fibrodysplasia ossificans progressiva and for those with metastatic uveal melanoma with unresectable hepatic metastases; and gastrointestinal associations issue a statement regarding GLP-1 use prior to upper gastrointestinal endoscopy.
Oral postpartum depression treatment approved; generic naloxone nasal spray now available; weight management drug shows promise in reducing major cardiovascular events; CDC recommends routine use of RSV vaccine; social anxiety disorder spray shows potential.
Drug agencies issue letter addressing the prescription stimulant shortage; electronic transfer of controlled substances given green light; oral contraceptives recalled; expanded indication for Ebola vaccine; and a new over-the-counter opioid overdose treatment.
Single-use application to treat the molluscum contagiosum approved; Xdermvy has gotten the green light to treat demodex blepharitis; warfarin reversal treatment for use in urgent surgery; weight loss drug in short supply through 2023; cervical pessary assessed for reducing preterm birth.
Study supports the benefit of potential new Alzheimer drug; RSV treatment approved for neonates and infants; Veklury approval expanded; a blood test used to diagnose life-threatening heart muscle injuries has been recalled; Brenzavvy available for adults.
First over-the-counter birth control pill; expanded approval for Leqvio; Gavreto has an indication withdrawn; batches of Albuterol inhalers recalled; results from analysis of paclitaxel-coated devices.
New approvals for alopecia, generalized myasthenia gravis and type 1 diabetes; New colonoscopy prep option; And FDA denies application for pre-chirrotic fibrosis due to NASH.
FDA revoke Emergency Use Authorization for a COVID-19 vaccine; New approval for treatment of iron deficiency in patients with heart failure; Lumryz now available for excessive daytime sleepiness; Vowst approved for C. difficile infection; Prevymis approved for prophylaxis of CMV disease in adult kidney transplant recipients.
New vaccine for lower respiratory tract disease; A new treatment for heart failure; Concerns over some compounded semaglutide; New opioid use disorder treatment; Motion sickness Tx shows promise.
First oral antiviral approved for COVID-19; First topical treatment approved for epidermolysis bullosa; Xacduro gets green like for bacterial pneumonia; New nasal spray for opioid overdoses; Child cough suppressant recalled.
FDA requires label updates for the entire class of prescription stimulants; Novel treatment approved for menopause symptoms; FDA Committee takes votes on potentially accelerated approval of Duchenne muscular dystrophy gene therapy; Fungal meningitis outbreak in US; Wearable child thermometer recalled.
Panel votes unanimously in favour of over-the-counter change for contraceptive pill; First pharmacological therapy for agitation associated with dementia due to Alzheimer disease; Elfabrio approved for the treatment of Fabry disease; Farxiga approval expanded; Bacterial contamination concerns for certain COVID-19 at-home tests.
Investigational treatment for early Alzheimer disease shows promise; First vaccine for the prevention of lower respiratory tract disease caused by RSV; Nightly granules approved for narcolepsy; Latest health tech advance in toilets; And the FDA warns of energy boosting over-the-counter inhalants.
Large recall of drugs due to company shutdown; First orally administered fecal microbiota treatment given green light; Treatment approved for certain ALS patients; Type 2 diabetes insulin delivery system; FDA issue safety alert concerning eyedrops.
Updates to COVID-19 vaccines; FDA panel votse on potential treatment for agitation with Alzheimer dementia; DEA deschedule drug; Migraine treatment indication expanded; A new device is cleared to aid in restless legs syndrome.
Implantable device approved for those with knee osteoarthritis; Prescribing Information labeling updated for opioids; Imbruvica indications withdrawn; Patch to combat excessive underarm sweating given green light; Novel treatment Fast Tracked for Type A and B influenza.
Treatment granted Emergency Use Authorization for hospitalized COVID-19 patients; Preterm-birth prevention treatment withdrawn from market; Sleep device for infants gets green light for marketing; New Padcev plus Keytruda indication; Mail-back system for unused opioids; Opioid overdose prevention device approved
Two diabetes drugs permanently discontinued; Consistent reduction in schizophrenia symptoms with an investigational Tx; Positive results for investigational Social Anxiety Disorder therapy; High-concentration Humira biosimilar approved; Sleep apnea treatment expanded for pediatrics with Down syndrome
COVID-19 Booster dose authorized for those aged 6 months through 4 years; Rapid STI point-of-care test for women is cleared; Rett syndrome and migraine Tx Approved; and The Oncology Drugs Advisory Committee takes a vote on a drug combination treatment for diffuse large b-cell lymphoma.
Limits on acetaminophen levels in combination opioid products linked to declines in liver injuries; Investigational Alzheimer disease drug fails to show efficacy; Bempedoic acid assessed for reducing major adverse cardiovascular events; Commercial blood test for suspected TBIs; Mammography regulations updated.
Kevzara approved for polymyalgia rheumatica; Skyclarys approved for Friedreich ataxia; Emergency authorization granted to at-home COVID-19, flu test; Drug-resistant bacteria virus spiking in the US; FDA clamps down on unlawful xylazine imports.
Results from postexposure prophylaxis study of molnupiravir; Treatment approved to reduce proteinuria in adults with primary immunoglobulin A nephropathy; Intravitreal injection approved for geographic atrophy secondary to AMD; Potential vaccines for melanoma and pregnant individuals to help protect from RSV complications in infants.
FDA Committee take vote on possible OTC Narcan; Rebyota available to prevent CDI recurrence; Risk of maternal sepsis lowered with azithromycin; Cinbinqo indication expanded; Topical treatment shows promise for hand eczema
Type 2 diabetes treatment discontinued; Depression, postpartum treatment gets Priority Review; Hypothyroid treatment recalled; FDA warns about weight loss supplement; First retinopathy of prematurity treatment for preterm infants approved.
The FDA make major revisions to COVID-19 antiretrovirals; Large study finds possible new indication for beta blockers; Jesduvroq approved; Artificial tears product recalled; Evusheld emergency use authorization halted.
FDA make major revisions to EUAs of COVID-19 antivirals; Large study finds possible new indication for beta blockers; Jesduvroq approved; Artificial tears product under investigation; Evusheld emergency use authorization halted.
Pfizer-BioNTech bivalent vaccine under investigation; Trial evaluating HIV prevention vaccine discontinued; Early detection sepsis test cleared; Trial results for RSV-associated disease vaccine; Combo Tx for HCC recurrence shows promise
FDA grant accelerated approval to Alzheimer disease treatment; New fixed-dose asthma treatment; NERD therapy looks promising; Leukemia drug to be withdrawn; Pertussis prevention treatment approved for use during pregnancy
Risk evaluation and mitigation strategy updated for abortion pill, mifepristone; Potential PTSD therapy shows positive results; A host of HIV meds are to be discontinued in the next year; Weight-loss treatment gains expanded approval in pediatrics; Experts rank their best diets for a variety of categories.
In this week's episode we interviewed Gretel Schueller, managing editor of health at US news, to discuss the results from this year's Best Diet rankings and the methodology used to compile the list.
Interim guidance for influenza treatment with limited oseltamivir; FDA panel vote on omecamtiv mecarbil; Tecentriq gains new indication; Potential combo COVID-19 and influenza vaccine; Detect COVID-19 tests recalled.
New authorization for COVID-19 vaccines in certain children; Narcan nasal spray to be reviewed for OTC status; Empagliflozin assessed in children with diabetes; a major depressive disorder therapy gains fast track status; and Tecentriq has an indication withdrawn.
FDA pull bebtelovimab; compounding guidance issued in light of the amoxicillin shortage; the first fecal microbiota treatment is approved; a treatment for Alzheimer disease agitation shows promise; and a gene therapy for duchenne muscular dystrophy is accepted for Priority Review.
Newly approved gynecologic cancer treatment; Zejula has it’s use restricted; intrauterine system use extended; a second insulin product is approved as a biosimilar to Lantus; and an FDA Advisory Committee take a vote on tenapanor.
USPSTF recommendations on estrogen and progesterone; semaglutide assessed in obese teenagers; efficacy and safety data released for maternal RSV vaccine; updates to clozapine REMS; FDA panel vote on investigational CNS/leptomeningeal metastasis treatment.
Approvals for relapsed or refractory multiple myeloma, non-radiographic axial spondyloarthritis, and unresectable hepatocellular carcinoma; advisory committee takes vote on potential treatment for anemia of chronic kidney disease; and an oral formulation of pulmonary arterial hypertension treatment.
FDA Panel votes on the potential removal from the market of Makena; results from an apixaban trial of patients with atrial fibrillation and valvular heart disease; reports of serious ocular complications with monkeypox infection; the novavax vaccine becomes the latest authorized COVID-19 booster; and treatments for nephropathy and ALS have their review period extended.
Bivalent COVID-19 booster vaccines for children; wearable device to help treat fluid overload in adults with chronic heart failure; real-world data insights into molnupiravir efficacy; vaccine for the third trimester of pregnancy to prevent pertussis; and an FDA update on apomorphine infusion in Parkinson disease.
ALS treatment news; Evusheld fact sheet update; an at-home epilepsy diagnostic aid gets cleared; drug recalls; and a laser therapy for fibromyalgia.
This week we go over warnings about a new social media challenge; treatment approvals in cisplatin-associated ototoxicity, cerebral adrenoleukodystrophy, MRI contrast agents and a generic version of tazorac.
Approvals in psoriasis, hepatorenal syndrome, and neutropenia; novel therapy gains Priority Review for Rett Syndrome; and the effects of multivitamin supplementation assessed on cognitive function.
Hello listener and welcome to episode 130 of the MPR Weekly Dose Podcast. This week we have news of the FDA’s vote on an ALS treatment; CPAP and BiPAP device recalls; Orphan Drug designation for a novel CRISPR therapy; Imfinzi gains new approval; and Spevigo is approved for pustular psoriasis flares.
Omicron-adapted COVID-19 booster vaccines; guidance for the 2022-23 influenza season; efficacy of COVID-19 antiviral; ‘rainbow fentanly’ targeting youth; and a device to treat chronic idiopathic constipation.
USPSTF recommendations on the use of statins for primary prevention of cardiovascular disease; At-home visual acuity test; A new treatment for major depressive disorder; Novavax COVID-19 vaccine approved for adolescents; And there is an alert regarding the potential risk of transmission of monkey virus through fecal microbiota transplantation.
USPSTF recommendations on the use of statins for primary prevention of cardiovascular disease; At-home visual acuity test; A new treatment for major depressive disorder; Novavax COVID-19 vaccine approved for adolescents; And there is an alert regarding the potential risk of transmission of monkey virus through fecal microbiota transplantation.
Novavax vaccine booster update; over-the-counter hearing aids; priority review for a castration-resistant prostate cancer combination treatment; a first gene therapy approved for beta-thalassemia; FDA urges repeat at home COVID-19 testing to reduce risk of missing infection.
New authorization for intradermal administration of monkeypox vaccine; a new approval for endometriosis pain; Amazon is among the companies to receive an FDA Warning Letter for selling unapproved drugs; a diabetes drug is found to contain a possible carcinogen; and a new scale that measures peripheral impedance and pulse rate.
A neurostimulation device has been cleared for post-C-section pain; a new plaque psoriasis treatment; the FDA address the contrast agent shortage; Lucentis biosimilar treatment is approved; and the recall for an over-the-counter laxative is expanded.
Novavax Emergency Use authorization; the Pfizer-BioNTech vaccine gets approval in adolescents; submission for oral contraceptive to be switched to over the counter; Astepro nasal spray gets over-the-counter approval; and Dupixent shows benefits in pediatric patients with eosinophilic esophagitis.
Pharmacists now allowed to prescribe Paxlovid; new dosing recommendations for Evusheld; abuse-deterrent opioid analgesic; priority review for early alzheimer disease treatment; morphine tablets recalled.
New nasal spray for allergic rhinitis; weight management drug indication is expanded to include teens; monkeypox vaccine access; COVID-19 antibody shelf-life extension; JUUL banned in the US.
Skyrizi gains new approval; the USPSTF make recommendations on multivitamin use to prevent CVD and cancer; an FDA Panel vote on pimavanserin efficacy for treating hallucinations associated with Alzheimer disease psychosis; Phexxi analysed in over 1000 patients; and Vaxneuvance approved for some pediatrics.
FDA panel vote on COVID vaccines for young children; new drug approved to treat alopecia; paxlovid tested in standard risk individuals; a device to aid autism diagnosis; and a new approval for polyneuropathy hATTR.
The FDA Advisory Committee vote on Novavax; new option for MMR vaccination; Dupixent approval expanded; and we take a look at the latest data on COVID-19 treatments.
Ukoniq, a treatment just approved last year, has been withdrawn; We rundown a host of drug pipeline news in asthma, dermatology and oncology; and there's positive results for a novel postpartum depression treatment.
The latest guidance for Paxlovid treatment following rebound reports; Dupixent gets a new approval; A new treatment is approved for plaque psoriasis; Update on the efficacy of a COVID-19 vaccine in those aged under 5; And the latest on Monkeypox.
The FDA decide to decline COVID-19 treatment; Booster doses authorized for children; A direct to consumer test to detect COVID-19, influenza, and RSV; And a wearable furosemide delivery system accepted for review.
Treatment approved for hospitalized COVID-19 patients; Update on Varenicline supply; Limits have been set for the Janssen COVID-19 vaccine; Safety alert issued for a COVID-19 test; And certain hemodialysis machines may carry the potential for chemical exposure.
This week: USPSTF recommendations on aspirin use to prevent cardiovascular disease; Veklury indication expanded; Accupril Lots recalled; Legal action on counterfeit HIV medication; And the White House releases plan to tackle the overdose epidemic.
This week: the halting of the sabizabulin trial in COVID-19; Emergency Use Authorization to be requested for booster dose in 5 to 11 year olds; Diversity in Clinical Trials; Myopericarditis risk compared for COVID-19 vaccines vs other vaccines; And survey results of unvaccinated attitudes following FDA approval.
A second booster dose for some COVID-19 vaccines is authorized; Sotrovimab has its use limited due to the BA.2 Omicron subvariant; An investigational oral antiviral gains Fast Track designation; PreHevbrio hepatitis B vaccine now available; And the FDA update a safety communication regard the risk of thyroid dysfunction in infants following the use of contrast media containing iodine.
Allergy treatment gets over-the-counter approval; Anaphylaxis treatment recalled; Phase 3 trial results for investigational sciatica treatment; FDA alert regarding at-home COVID tests; And the resubmitted Biologics License Application for teplizumab for type 1 diabetes is accepted.
In this week’s special episode of The Weekly Dose Podcast we interview Dr Tobias Janowitz, a medical oncologist, assistant professor at the Cold Spring Harbor Laboratories and adjunct professor at the Feinstein Institutes. Dr Janowitz was part of a team that recently conducted a phase 2 clinical trial assessing high doses of famotidine in adults with COVID-19. The trial was conducted completely remotely and the findings were published in Gut. As well as discussing their findings, Dr Janowitz talks about the process of conducting a fully-remote trial and the greater possibilities this may hold for future clinical research.
A new injection is approved for opioid overdose; The Advisory Committee on Immunization Practices releases vaccine schedules; The FDA provides a list of approved COVID-19 tests; A trial of an investigational spontaneous urticaria treatment is stopped; And the first condom is authorized for anal intercourse.
This week in COVID related news, a heartburn medication shows benefit in patients; Bebtelovimab is authroized; Veklury is shown to retain antiviral activity against variants. Away from COVID, a functionally scored carbidopa/levodopa tablet is now available for Parkinson disease, and the FDA issue a ketamine compounding warning.
This week: news of millions of courses of a COVID-19 oral antiviral being provided to the US government for distribution throughout the country; There’s a draft guidance for novel nonopioid analgesics; Possible strangulation warning for enteral feeding tubes; A new treatment has been approved for cold agglutinin disease; And a treatment is under review for HFrEF.
This week: The approval of a second COVID-19 vaccine; Pfizer and BioNTech submit for Emergency use of their vaccine for children under 5; Pfizer have also stopped development on a potential drug treatment to reduce cardiovascular risk and severe hypertriglyceridemia; And new dosing options for a HIV drug.
Use of monoclonal antibodies restricted due to Omicron; Veklury given the go-ahead as an outpatient treatment; New data produces a reconsideration for Pepaxto withdrawal; And there's a new treatment approval for unresectable or metastatic uveal melanoma.
This week we have news of two new approval for atopic dermatitis; Warnings around counterfeit HIV treatments; Zydelig indications withdrawn; CDC pediatric influenza vaccine study results; And an FDA warning against a particular brand of COVID-19 antibody tests.
This week: Novel insomnia treatment; The FDA comment on magnesium hypertension claim; Transmucosal buprenorphine linked to dental decay; Researchers assess changes in menstrual cycle in relation to COVID vaccines; And experts have their say on the best diets for 2022.
Contraindication added to Janssen COVID-19 vaccine; Pfizer announce final results for their COVID-19 oral antiviral; A new treatment for benign prostatic hyperplasia; REMS change for CAR T-cell therapy, and Rinvoq gains approval for active psoriatic arthritis.
This week we bring you up to speed on a lot of COVID-related news, despite the emergence of Omicron, there is positive news; Evusheld has become the first pre-exposure prophylaxis for COVID-19; Data shows that the Pfizer-BioNTech booster dose offers protection against Omicron; Monoclonal antibody therapy is authorized for kids; Heterologous boosting may be more beneficial than homogeneous; and important info about some Veklury lots being recalled.
We made it to 100! This week Pfizer seeks Emergency Use Authorization for their COVID oral antiviral; A meta-analysis found commonly prescribed drugs were linked to orthostatic hypotension; A novel treatment is approved for polycythemia vera; A new program has been cleared to allow individuals to carry out remote endoscopy procedures; And the largest to date psilocybin trial shows promise in treatment-resistant depression.
This week there’s positive news for the COVID-19 oral antiviral candidate, Paxlovid; The CDC expands a recall for aromatherapy sprays connected to fatal cases of a rare tropical disease; The first eye drop to treat presbyopia is approved; An alternative to naloxone gets fast tracked; And a study compares the migraine treatments erenumab and topiramate.
The FDA votes on whether the Pfizer-BioNTech vaccine should be authorized in 5 to 11 year olds; The Moderna vaccine elicits strong antibody responses in pediatrics; Trial results shed light on booster dose efficacy; Shingrix is recommended for immunocompromised patients; A novel treatment is approved for macular edema associated with uveitis; And Pepaxto is withdrawn following new findings.
This week: big news announced in COVID-19, with the FDA stating that mixing and matching of vaccines for the booster dose is authorized. The first interchangeable biosimilar to Humira is approved. Also there’s approvals for dry eye disease, pain management and opioid overdoses.
This week the USPSTF update aspirin recommendations for those 60 years and older; The FDA take a stance on needle-free devices for injecting dermal fillers; REMS requirements are updated for isotretinoin products; A new treatment approved for pediatric congenital athymia; An emergency use request submitted for an oral antiviral COVID treatment; And the FDA advisory panel vote on boosters for the Moderna vaccine.
Dr Preeti Malani, Chief Health Officer at UM, joined us to talk about the current state of the COVID-19 pandemic, including vaccine hesitancy, mandates, boosters and how the future may unfold.
The Pfizer-BioNTech vaccine gets Emergency Use Authorization for booster dose in certain individuals; A smaller dose appears safe and effective in children; Janssen share booster data for their vaccine; A survey sheds light on parents’ thoughts on child COVID vaccination; Remdesivir efficacy data in COVID-19 patients, And Opzelura is approved for atopic dermatitis.
This week the FDA weigh up mandatory education for opioid prescribers; There’s an increase in the sale of strong psychoactive THC products; Brukinsa and Exkivity gain approvals for lymphoma and NSCLC, respectively; And a number of supplement companies received FDA warning letters.
This week we have news on pediatric influenza vaccine guidance; Moderna submit data for their COVID-19 booster dose; There’s new FDA warnings for some JAK inhibitors; Trudhesa nasal spray is approved; And the FDA places a clinical hold on a gene therapy for phenylketonuria.
The first COVID-19 vaccine is fully approved by the FDA, we'll go into all that that entails and also news regarding booster doses, off-label recommendations, promising antibody treatments and a BLA submission from Moderna for their vaccine.
This week we have significant news on the status of a third COVID-19 vaccine booster dose, as well as news for an encephalitis vaccine, another jardiance indication, an FDA warning concerning patient wristbands, and Jemperli gets accelerated approval.
Big news on the COVID-19 vaccine booster dose. The CDC issues new recommendations on vaccines. What protection the Moderna vaccine offers after 6 months. A treatment approved for Pompe disease. And the FDA denies an application for a new roxadustat indication.
The FDA authorizes a postexposure prophylaxis for COVID-19; a new treatment is okay’d for lupus; a higher dose naloxone nasal spray became available; the risk evaluation and mitigation program for Clozapine has had important changes, and finally, Istodax has had an indication withdrawn.
This week we have news of the FDA requesting a change to statin prescribing labels, a new vaccine for streptococcus pneumoniae, a new plaque psoriasis cream, a stem cell therapy gets fast tracked as a possible Parkinson disease treatment, and there’s a new treatment approved for Progressive Familial Intrahepatic Cholestasis (PFIC).
This week on the pod we speak about a fact sheet update for the Janssen COVID vaccine. Pfizer and BioNTech are working on a booster version of their vaccine. A supplement is found to contain a prescription ingredient. There’s a new treatment for patients with diabetic kidney disease. And two popular sunscreen brands are recalled due to the presence of benzene.
This week Pfizer recalled their smoking cessation therapy Chantix. A treatment for acute bacterial skin and skin structure infections becomes available. Aduhelm, the newly approved Alzheimer Disease treatment, has its label updated. A blood lead level test is recalled, and there's updates to the cancer drug Keytruda.
The FDA grants Emergency Use to Actemra to treat hospitalized COVID patients. Revisions are been made to the fact sheets for the Moderna and Pfizer BioNTech COVID vaccines to include information related to the risk of myocarditis and pericarditis. A new treatment is approved for some cancer patients allergic to E. coli-Derived asparaginase products. Solosec gets an expanded indication and a new drug application for a HIV-1 treatment has been submitted.
This week the FDA approved a first-in-class switch for an antihistamine nasal spray, a new oral contraceptive, and Pradaxa was approved to prevent venous thromboembolism in pediatric patients. Meanwhile, real-world data on the efficacy of the COVID-`9 treatment remdesivir has been published.
This week the FDA approved a regenerative skin tissue therapy and a treatment for advanced mastocytosis, while Novavax’s vaccine for COVID and a novel treatment for MDD show promise. Also the FDA issue warning concerning hand sanitizers.
This week it's the big one: aducanumab - a treatment for alzheimer disease - got FDA approval. We’ll go into that, plus a semaglutide treatment for obesity, a first treatment for Plasminogen Deficiency Type 1, and Moderna have sent a request for an EUA to extend the use of their COVID-19 vaccine to those aged over 12.
On this week's show we have news of migraine prevention treatment, a hexavalent vaccine is approved for pediatrics, there’s also an approval for schizophrenia and bipolar I disorder, lumakras gets fast tracked and there’s a new diagnostic aid for Autism, and it is artificial intelligence.
This week we have news of a change to the storage of the Pfizer-BioNTech vaccine; A gene therapy gets Fast Track status by the FDA; Vitiligo cream shows promise in clinical trials; And outcomes in atherosclerotic cardiovascular disease are compared for different aspirin dosages.
This week we have news of a COVID-19 vaccine authorization expanded for adolescents; A new postoperative pain treatment; There’s a new insulin smart pen devices; Insulin products are recalled; And the FDA grants fast track status to a potential treatment for the rare disease, FSHD.
New guidelines on mask use; J&J vaccine update; Novel major depressive disorder treatment gains Priority Review; A scabies topical suspension; And a device to help stroke rehabilitation.
The FDA revoke Emergency Use Authorization for bamlanivimab; Issues identified at a Janssen manufacturing facility; Merck halts trials for investigational COVID-19 therapy; A new contraceptive is approved; And Ragwitek has approval expanded.
The latest status on the Janssen vaccine; Updated guidance from the National Institutes of Health on COVID-19 antibody treatments; The FDA changes in-person mifepristone dispensing; Xolair prefilled syringe approved for self-administration in select patients; And the AI world comes to colonoscopies.
Back to regular programming this week with a summary of the top news, which includes updated travel guidance; Six month efficacy data for the Moderna and Pfizer-BioNTech vaccines; Vial doses increased for Moderna; A new ADHD drug is approved; And the FDA has issued a safety communication regarding the potential increased risk of arrhythmias in patients taking lamotrigine.
With three FDA authorized vaccines being administered throughout the US, but new variants growing in number, we are at a crucial moment in the COVID-19 pandemic.
To get a better understanding of how the future months could unfold, MPR sat down with Dr Joshua Barocas, an assistant professor of medicine at the Boston University School of Medicine and also an Infectious Diseases physician at Boston Medical Center.
This week we have new study data on the real-world effectiveness of the Pfizer-BioNTech vaccine; The number of Americans who are completing both vaccine doses; A vaccine trial that has started in children; And an approval in acute bacterial skin and skin structure infections.
This week it's all COVID related news; There’s new CDC guidance for those who are vaccinated; A first over the counter test that doesn’t require a prescription; Nasopharyngeal povidone iodine and the combo of Bamlanivimab-Etesevimab is assessed; And there’s reports of vaccine local reactions.
This week we have news of an indication for the cancer treatment, Keytruda, being withdrawn; Janssen’s single dose vaccine gains Emergency Authorization; There’s findings on the effectiveness of Ivermectin as a therapy for mild COVID-19; And devices to treat migraine and prevention of sub-concussive head impacts are authorized for marketing.
An FDA warning over pharma company's promo material; Entresto's approval is expanded, There’s approvals in homozygous familial hypercholesterolemia and chronic inflammatory demyelinating polyneuropathy; And a migraine device for OK'd for teens.
This week’s stories include a caution about remdesivir; New and updated Emergency Use Authorizations; And new approvals in sleep apnea and for Botox.
This week we take a look at the remaining prospective COVID vaccines, that includes AstraZeneca, J&J and Novovax; There’s also drug approvals for analgesia and influenza.
On this week’s pod: The Moderna vaccine and what we know about its effectiveness against emerging variants; Merck ends it’s development of two vaccines; Two separate treatment combos show promise in reducing hospitalizations and preventing COVID, respectivel; And the FDA approve a new treatment for lupus nephritis.
On this week’s MPR pod we take a look at the current status of Johnson & Johnson’s COVID-19 vaccine candidate; Considerations in assessing blood donors during the pandemic; A newly approved drug to treat heart failure; Promising results for a potential Alzheimer treatment; And changes declared for vinca alkaloid labeling.
This week we have news of the neutralizing response of the Pfizer-BioNTech vaccine to the new COVID-19 variant; A trial investigated ravulizumab in adults with severe COVID is halted; A rapid blood test for concussions gets the all clear; A novel treatment for chronic kidney disease in patients with type 2 diabetes; and the drug manufacturer Fresenius Kabi announces a voluntary recall of one lot of an NSAID treatment.
On the first MPR pod of 2021 we cover the latest COVID-19 news including admin. scheduling and production news; A diagnostics test that is giving false negative results; Bristol Myers Squibb withdraw an indication for Opdivo; And experts vote on the best diets for 2021.
Its been a long year, but the monumental efforts to achieve a COVID-19 vaccine are bearing some fruits, we about that, and also a fully at home diagnostic COVID test, as well as new findings related to glucosamine supplements and a novel treatment for eosinophilic esophagitis.
This week we cover new findings for the diabetes drug sitagliptin in pediatrics; An obesity treatment has approval expanded; The FDA issue a Complete Response Letter for an outpatient alternative treatment; And news of availability for a transdermal contraceptive patch.
This week we cover a back and forth between the FDA and the WHO over remdesivir efficacy; Recommendations for who should get a COVID vaccine first; Xolair and Hetlioz have approval expansions; And a novel neuroblastoma treatment gets accelerated approval. Moreover, there's movie trivia!
The latest on vaccine news from Moderna, and BioNTech and Pfizer as they release more trial data; A at-home diagnostic test is approved; Keytruda gains expanded approval; and all the rest of the drug news from this past week.
Major developments in COVID-19 vaccine and antibody treatments: Are we close to having a vaccine gain Emergency Use Authorization? The antibody bamlanivimab is given Emergency Use Authorization; An NIH study concluded that hydroxychloroquine has no clinical benefit; And unrelated to COVID, but still big news, the Advisory Committee have voted on what would-be the first Alzheimer disease treatment in decades.
This week we cover a new treatment submission to the FDA for the prevention of diabetes; The launch of a bupivacaine implant to treat post op pain; The DEA schedules a newly approved opioid; The FDA classifies over 200 drugs as essential and wants manufacturers to ramp up production; And more news on drugs that are in the pipeline.
This week: The study that identified factors associated with strong antibody responses to COVID; How convalescent plasmas benefits may be limited; A nasal spray to treat diabetic gastroparesis; Recommendations for colorectal cancer screening; And a new treatment approved for dry eye disease.
This week on the pod: Results from the survey assessing willingness to receive a COVID vaccine; Dr. Fauci shares that he is 'cautiously optimistic' a vaccine could arrive before year’s end; A short course of treatment for tuberculosis shows promise; Phase 3 results for a novel pneumococcal vaccine; The FDA rejects a patch intended to treat migraines; And the breaking news that remdesivir (Veklury) has gained FDA approval.
This week: News of another vaccine trial being put on hold; A trial assessing hyperimmue globulin beings; An NDA for IV tramadol is rejected; FDA Committees vote on novel schizophrenia and bipolar I disorder therapy; And a first approval for Ebola.
This week on the pod; the latest COVID news, including encouraging news on antibody therapies; Updated on Emergency Use Authorization guidelines for vaccines; Remdesivir distribution; A HIV drug fails to have an impact; And why the FDA want a preterm birth treatment withdrawn from the market.
New Moderna vaccine results; Boxed Warning for benzodiazepines; Point-of-care COVID-19 antibody test; Diphenhydramine overdoses linked to TikTok ‘Challenge’; And FDA grants Nucala new approval. Also we look at this week's developments in drugs in the pipeline.
This week we cover AstraZeneca and the swift decision to restart their COVID-19 vaccine candidate trial; Pfizer and BioNTech want to expand enrollment for theircandidate vaccine trial; There’s the janus kinase inhibitor that could help reduce recovery time; An investigative antiviral may ease strain on hospitalizations; Aortic aneurysm, dissection assessed with fluoroquinolones; and a retrospective study compared cardiac events with azithromycin and amoxicillin use.
We cover AstraZeneca’s decision to pause their COVID-19 vaccine trial; New studies indicate benefits for steroid therapy in COVID patients; Higher doses of diabetes treatment gain approval; The first non-hormonal contraceptive is launched; The FDA issues a letter regarding spinal cord stimulators; And we wrap up the latest news on drugs in the pipeline.
The ACIP release guidelines for the 2020-2021 vaccination recommendations; In COVID, there’s developments in convalescent plasma authorization; A 15 minute test; And ethnobotanist’s give a stark warning concerning a plant that some are touting as a cure; In other news an intrauterine device gains expanded approval; Label update for hydrochlorothiazide.
Treatment shows promise for patients who had pneumonia associated with COVID-19; A COVID-19 test that may have given inaccurate results; Neck gaiters as face masks may actually spread the virus; Drug applications are halted by the FDA; And Narcan has it’s shelf life extended. Also, we recap drug pipeline news from the past week.
Remdesivir is submitted; New opioid approved by FDA; A new Spinal Muscular Atrophy treatment; A sublingual epinephrine treatment; and the latest on Biogen’s investigational Alzheimer disease treatment.
This week there's more COVID vaccine developments; A first-of-its-kind trial assessing a drug for preventing COVID in long term care facilities; A cannabidiol treatment gains another indication; Depression treatment gains indication for major depressive disorders with acute suicidal ideation or behavior; And the FDA requests more information for their review of the peanut allergy treatment, Viaskin.
It’s been an important week with big developments in potential COVID-19 vaccines; News on how steroid therapy may help some COVID patients; There’s results from the Actemra trial in COVID pneumonia patients; News that sputum samples may be just as effective as nasopharyngeal samples for detecting sars-cov-2; And researchers have linked vaccination to reduced risks of Alzheimer disease.
This week: The government makes a $1.95 billion deal for a COVID-19 vaccine; Promising data from the Oxford vaccine trial; The CDC retakes control of COVID-19 data; Novel calcineurin inhibitor for lupus nephritis gets priority review; And there’s new treatment for narcolepsy.
This week; Significant moves in COVID-19 vaccine development; Research finds a link between PPI use and increased risk of COVID-19; We look at remdesivir’s efficacy in severe COVID-19 cases; And several Company’s recall their metformin extended release tablets.
The discontinuation of a trial investigating a potential COVID-19 treatment; A safety alert for toxic hand sanitizers; Vaccine guidance in the time of the pandemic; And new treatments in HIV and myelodysplastic syndromes.
This week on the Pod: The FDA issues guidance for COVID-19 vaccine development; Accuracy in COVID-19 antibody testing; How statins may improve outcomes for hospitalized COVID-19 patients; and in non-COVID-related news there’s a new drug approvals in breast cancer and Dravet syndome.
This week on the Pod: Over-the-counter med recalls; a nasal spray approved for diabetic gastroparesis; reports of an uptick in penicillin-, ciprofloxacin-resistant meningococci; and in pandemic-related news, a possible inhaled version of remdesivir, and colchicine as a potential treatment.
This week we cover the latest in the rapidly shifting perception of chloroquine and hydroxychloroquine; The polio vaccine as a potential protector against COVID-19; A new approval for Gardasil 9; And the American Gastroenterological Association draw up new guidelines for probiotic use as a treatment in gastrointestinal disorders.
This week on the pod we cover the latest COVID19 news, including antibody tests and their accuracy; A study aiming to examine treatments in children; The potential benefit of Acalabrutinib in severe cases; The WHO’s Technical Lead on COVID-19 having to backpedal a statement on transmission; And many states lodge record high numbers of infections.
This week on the pod we look at results from a COVID-19 prevention trial of hydroxychloroquine; A vaccine arrival date prediction by Dr Fauci; A FDA notification regarding vial caps; A look into prescription patterns during COVID-19; And an antibody treatment trial begins.
Today's pod covers important news regarding hydroxychloroquine; The efficacy of dietary supplements as a means to manage or prevent COVID-19; The first non-hormonal contraceptive gel approved by the FDA; And an expanded approval for dupilumab.
This week we cover the latest COVID-19 developments including: reports of false negatives with Abbott’s diagnostic test; the immune globulin therapy linked to recovery in multisystem inflammatory syndrome in children, related to COVID-19; and the clinical trials set to be initiated for an umbilical cord stem cell therapy and a high dose IV immune globulin therapy.
This week we cover the latest COVID-19 developments including a triple antiviral therapy that looks promising, Emergency Use Authorizations granted to diagnostics and critical meds, Moderna’s investigational vaccine gets Fast Tracked, and the National Institute of Health’s remdesivir plus baricitinib trial.
This week we cover the the risk of antihypertensive med use during the pandemic; The Emergency Use Authorization for remdesivir in hospitalized patients with suspected or confirmed COVID-19; The addition of a Boxed Warning to Montelukast; A new Farxiga indication; And a novel treatment for acute migraines.
There has been a lot of recent developments in possible COVID-19 treatments. I’ll go over the latest status with remdesivir, hydroxychloroquine, sarilumab, and remestemcel-L, and also the treatment guidelines for COVID-19 issued by the National Institute of Health.
On today’s podcast we run through the top COVID-19 stories including a steep rise in poison control calls; the authorization of an at-home testing kit; The hydroxychloroquine trial that’s beginning soon; The trial evaluating ruxolitinib for COVID-19 associated cytokine storms; and the lab failures which have led to ineffective COVID-19 tests being sent from the CDC to nearly all of the 100 state and local public health labs.
We run through the latest COVID-19 news including results from a remdesivir trial; The blood purification system OK’d for patients in the ICU; A chloroquine trial halted early due to deaths; The saliva test that detects COVID19; And a bleaching agent product that is claiming to prevent COVID-19.
This week we run through the latest COVID-19 news including the shortage of critical meds, The CDC U-turn on face mask recommendations, Remdesivir trial enrollment, testing for COVID-19 antibodies, and new guidance from the FDA on blood donations aimed at helping maintain the supply.
This episodes covers the latest COVID-19 news including drug shortages, a new point-of-care diagnostic tool, the role of vitamin C, misuse of non-pharmacological chloroquine, and also some big news about a popular heartburn drug.
This week we talk about the latest on COVID-19, including the virus in relation to NSAID use; the pandemics knock on effect on drug shortages; a safety alert for fecal microbiota transplants; and potential flaws in EpiPen devices.
This week we talk about a phase 1 vaccine trial for COVID-19 underway in Seattle; Concerns over COVID-19 and ACE inhibitor, ARB use; Safety labeling changes for SGLT2 inhibitors; A biosimilar to Herceptin; And new graphic warnings for cigarette packages.
Today we talk about the latest COVID-19 news; New approvals for chronic fibrosing interstitial lung diseases and Cushing disease; and stronger safety warnings for montelukast.
Today we talk about the ban on certain electrical stimulation devices, the latest COVID-19 news, a first generic of Daraprim, a New Drug Application for a potential microneedle migraine treatment patch, and a first over-the-counter combination of ibuprofen and acetaminophen: Advil Dual Action.
This week on the pod we cover a first-in-class cholesterol lowering therapy; a new indication for Trulicity; Macrolide prescriptions in the first trimester and their relation to fetal malformations; a new fragile X diagnostic test; and a migraine prevention IV treatment.
This week on the pod we cover the withdrawal of Belviq, the weight-loss drug, from the market; the over-the-counter approval of diclofenac gel and olopatadine eye drops; a new contraceptive transdermal patch; a possible vaccine for ricintoxin; and new research finds that hundreds of sellers are using Craigslist to sell prescribing medications.
This week on the pod we cover an insulin pump recall; Pharmacies running out of supplies in light of Covid-19 fears; Investigational Alzheimer disease treatments not meeting trial end points; A new cardiac ultrasound device; and a new oral testosterone replacement therapy.
This week on the Pod we cover the approval of the first oral therapy for peanut allergy; The 2020 immunization schedule; The latest on the coronavirus, including the CDC's shipment of test kits; The withdrawal of an antibiotic; and results from the FDA investigation into possible impurities in metformin.
This week we discuss the latest news surrounding the novel coronavirus, including the WHO's decision to declare the virus a global emergency; A new triple combo therapy in type 2 diabetes; Updated Tdap vaccination recommendations; An FDA warning regarding serious clozapine side effects; And news of possible cybersecurity vulnerabilities with certain patient monitoring devices.
This week we cover the CDC coronavirus health advisory; A possible oral influenza vaccine; A new treatment to reduce the risk of MACE; An FDA Committee vote; And the first approved treatment for thyroid eye disease.
This week we cover the approval of a cocaine nasal solution; 23andMe’s entry into the drug development; The recall of an epilepsy and bipolar treatment; A new nasal spray for seizure patients; And the weight loss drug that may be linked to cancer.
In our first episode of 2020 we cover new management guidelines in osteoarthritis; Recommendations for the use of testosterone therapy; The best diets for 2020; Two drug recalls; And a new drug approved for the treatment of migraines.
Back from our Thanksgiving break, this week we talk about the new approval for sickle cell disease; the re-introduction of a product that was taken off the market in the 60's; The first ready-to-use phenylephrine injection; A new ultrasound enhancing agent; And an approval for arthritis.
This week on the Weekly Dose we talk about the first lung transplant due to vaping-related illness; A new approval for patients with beta thalassemia; Opioids in osteoarthritis; A new, free test to help diagnose COPD; and news of a potential new therapy for hypercholesterolemia.
This week we talk about NDMA findings in ranitidine products; Approval of a new flu vaccine; The return of an antiarrhythmic agent; A new treatment for H. pylori infection; and the risk of biotin interference in test results which could lead to missed diagnoses.
This week we talk about the recall of an anti-anxiety med; Possible withdrawal of Makena; New MS treatment approved; IUD approved for up to six years; and time of day when meds taken could affect CVD risk.
This week we talk about the resurrection of Biogen's novel Alzheimer treatment; A "landmark" approval in cystic fibrosis; Expanded indication for Farxiga; The first topical minocycline formulation for acne vulgaris; and the Johnson's baby powder recall.
This week we talk about new treatment approvals for acute migraine, dry eye disease and schizophrenia; a new indication for Xarelto; and the Centers for Disease Control and Prevention issue an interim guidance for physicians regarding electronic cigarette, or vaping, product use-associated lung injury, or 'EVALI'.
This week we talk about the FDA highlighting THC in the recent spate of vaping-related illnesses; Descovy's expanded approval; A new cream for acne; A treatment for the rare condition possibly behind the creation of vampire myths; and a new drug approval for the treatment of wet age-related macular degeneration.
This week: New Invokana approval; More ranitidine recalls lead CVS to suspend all sales; FDA has identifies 11 serious cybersecurity vulnerabilities that could affect medical devices and hospital networks; Entresto indication expanded; and COPD investigate treatment is rejected.
This week: A new tablet treatment for type 2 diabetes; Pancreatitis treatment gains Orphan Drug status; New approval for smallpox, monkeypox; An investigational treatment for Guillain-Barré Syndrome; and big changes at e-cigarette maker, Juul.
This week: FDA votes on possible peanut allergy treatment; New risks ID'd with some breast cancer drugs; a topical solution for common warts edges nearer; Nitrosamine impurity identified in acid suppressant; And news of another e-cigarette related fatality.
This week: New adjunct treatment for Parkinson disease; Pain med associated with hypoglycemia; New approval for active ankylosing spondylitis; Fast track designation for possible kidney disease therapy; and a possible treatment for degenerative disc disease.
This week: New draft guidelines for Lyme Disease management; First-in-class antibiotic to treat community-acquired bacterial pneumonia; Duchenne muscular dystrophy drug denied; Approval for a rheumatoid arthritis treatment; and the FDA make a decision on Hetlioz for jet lag disorder.
This week the team discuss the ‘Cure All’ treatments that contain bleach, news concerning a Parkinson disease treatment, a new approval for a tuberculosis treatment, differences between the US and Canada in prescription drug use, and a new point-of-care, sexually transmitted infection test.