F.D.A. Expands Access to Clozapine, a Key Treatment for Schizophrenia
Federal regulators will no longer require patients to provide blood tests before receiving the drug from pharmacies.
Map Shows States With Listeria Cases as FDA Recalls Nutritional Shake
A nationwide recall of frozen nutritional shakes has been issued after a listeria outbreak tied to the drinks resulted in ...
Oops! Trump Accidentally Fired FDA Medical Device Reviewers
The Food and Drug Administration is scrambling to bring back hundreds of critical workers laid off en masse by DOGE.
Smokescreen: some vape firms pivot after FDA crackdown
Some e-cigarette companies targeted by U.S. authorities have altered their business model or changed their corporate ...
Drug compounders sue over weight loss drugs’ removal from FDA shortage list
A trade group representing compounding pharmacies has filed a lawsuit against the Food and Drug Administration (FDA) for ...
FDA delays when a final rule on what foods can be labeled as ‘healthy’ goes into effect
The FDA's new standards for foods before they can be labeled as "healthy" on their packaging will go into effect about two ...
The National Law Review12h
GLP-1 Drugs: FDA Removes Semaglutide from the Drug Shortage List
On February 21, 2025, the U.S. Food and Drug Administration (FDA) issued a Declaratory Order determining that the semaglutide ...
STAT15h
Trump’s FDA navigates layoffs, exits, and a new hire
The Trump administration has started rehiring some of the FDA employees it fired last week, the latest chapter in a haphazard ...
Targeted Oncology10h
FDA Grants Perioperative Pembrolizumab Priority Review in HNSCC
The FDA granted priority review to pembrolizumab for neoadjuvant and adjuvant use in head and neck squamous cell carcinoma, ...
uniQure N.V.: A Potential Huntington's Play
Qure's stock rises on Huntington's therapy progress and strong gene therapy pipeline. Learn about QURE stock's cost-cutting ...
BioPharma Dive13h
Drug compounders sue FDA over declaration ending Wegovy shortage
Telehealth provider Hims & Hers said it will tell consumers they need to seek “alternative options on the commercial dosing,” ...
Pharm Exec13h
FDA Grants Priority Review to Merck’s Keytruda for Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma
Keytruda demonstrated a statistically significant and clinically meaningful improvement in event-free survival and major ...