MPR Weekly Dose

First treatment approved for Alexander disease; Hyrnuo and Etcamah are approved for lung cancer and breast cancer, respectively; Pelacarsen misses endpoint in the phase 3 HORIZON trial, and atogepant shows promise from relieving menstrual migraines.   

Mounjaro approval expanded to reduce the risk of major cardiovascular events; The American Academy of Pediatrics has issued updated recommendations for RSV immunization; BTK inhibitor shows promise in relapsing MS; and The FDA adds a boxed warning to Injectafer.

Mounjaro approval expanded to reduce the risk of major cardiovascular events; The American Academy of Pediatrics has issued updated recommendations for RSV immunization; BTK inhibitor shows promise in relapsing MS; and The FDA adds a boxed warning to Injectafer.

In a special episode of the MPR Weekly Dose podcast, Dr William Schaffner — professor of preventive medicine and infectious diseases at Vanderbilt University School of Medicine and former CDC Epidemic Intelligence Service officer — discusses the clinical rollout of mFlusiva, the newly-approved mRNA-based influenza vaccine. Dr Schaffner breaks down how this modern platform differs from traditional egg- and cell-based manufacturing, detailing its mechanism of action as a genetic "blueprint" and analyzing the trial data behind its approval for adults aged 50 and older.  Beyond the science, Dr Schaffner offers actionable guidance for health care providers navigating the realities of modern clinical practice. He addresses practical logistics like coadministering mFlusiva alongside routine fall immunizations, including COVID-19, RSV, and pneumococcal vaccines. He also offers empathetic strategies for overcoming vaccine hesitancy, urging clinicians to look beyond technical lectures and focus on patient reassurance and emotional comfort.

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.