The Latest Breaking News from FDA

Anthony Fauci Under Fresh Fire As FDA Chief Makary Argues COVID-19 Lab Leak Theory Was 'Massive Cover-Up:' 'It's A No Brainer...'

The U.S. Food and Drug Administration’s (FDA) top official ignited fresh debate on Wednesday by accusing Dr Anthony Fauci on the “Pod Force One” podcast of suppressing early scrutiny of COVID-19’s origins, calling the alleged effort a “massive cover-up” during the first months of the pandemic.

Benzinga · Nov 27, 2025

Novo Nordisk Wants FDA Nod For A Higher-Dose Wegovy

On Wednesday, Novo Nordisk A/S (NYSE:NVO) submitted its supplemental marketing application to the U.S. Food and Drug Administration (FDA) for a higher dose of semaglutide injection 7.2 mg for chronic weight management.

Benzinga · Nov 26, 2025

BiomX Awaits FDA Clearance To Restart Cystic Fibrosis Trial After Nebulizer Device Review

BiomX Inc. (NYSE:PHGE) on Tuesday announced that the U.S. Food and Drug Administration (FDA) is continuing its evaluation of the nebulizer device used for drug administration in the company's Phase 2b trial of BX004 in cystic fibrosis patients.

Benzinga · Nov 26, 2025

Sarepta Secures FDA Nod For Elevidys Study To Reduce Liver Injury Risk

The U.S. Food and Drug Administration (FDA) on Tuesday approved dosing in Sarepta Therapeutics Inc.’s (NASDAQ:SRPT) Cohort 8 of ENDEAVOR (Study 9001-103).

Benzinga · Nov 25, 2025

'Catch Kits' for Fetal Remains Are Republicans' Latest Dystopian Plan To Punish Abortions

GOP lawmakers in Wisconsin and elsewhere are pushing the idea that abortions are a water quality issue.

Reason · Nov 24, 2025

The Surprising Way to Reduce Your Dementia Risk

Lower your dementia risk with this one hack.

Kiplinger · Nov 24, 2025

Can Your Pacemaker Be Hacked? The Hidden Threat in Connected Medical Devices

Imagine carrying a device inside your chest that keeps you alive, yet could be accessed by hackers. Pacemakers and other connected medical devices are designed...

Saving Advice · Nov 24, 2025

Why Is Biogen Stock Trading Higher After Semaglutide Alzheimer's Data?

Biogen Inc. (NASDAQ:BIIB) stock traded higher after Novo Nordisk A/S (NYSE:NVO) released disappointing topline results from the 2-year primary analysis of Evoke and Evoke+ phase 3 trials in early-stage symptomatic Alzheimer's disease.

Benzinga · Nov 24, 2025

The Short-Sellers May Be Right About This Red-Hot Pharma Stock

Palvella Therapeutics (PVLA) is a clinical-stage biopharma stock with no revenue or FDA pipeline. However, the stock has exceptional price momentum with shares up 508% over the past year. PVLA is trading at a new 2-year high and has strong technical indicators. Palvella is highly speculative. It is suitable for...

Barchart · Nov 24, 2025

Months Before the ByHeart Recall, Babies Were Already Sick — Parents Ask Why Early Warning Signs Were Missed

ByHeart's voluntary recall of its infant formula this November has raised concerns after families reported babies falling ill months earlier, highlighting potential delays in outbreak detection and regulatory response.

International Business Times UK · Nov 24, 2025