The telehealth company Hims & Hers put out a Super Bowl ad that skimped on clarifying that its compounded semaglutide ...

The FDA has updated the product labeling for Xeloda and 5-FU to highlight the risks associated with dihydropyrimidine ...

Dr. Gabriel A. Brooks discusses the recent FDA product labeling update for Xeloda and 5-FU which aims to highlight risks associated with DPD deficiency.

The Hims & Hers planned Super Bowl ad buy – and the content of that ad – is noteworthy, but not because it violates any ...

Wetherill to lead the Division of Chemistry, which would become the Bureau of Chemistry in 1901 and the Food and Drug Administration in 1906 ... industry actions without mandating specific ...

FDA published two final guidance documents related to food allergens: Questions and Answers Regarding Food Allergens, ...

A voluntary recall was initiated by The W.S. Badger Company due to missing labels on a sunscreen product distributed nationwide.

On January 16, 2025, the U.S. Food and Drug Administration (“FDA”) published a highly anticipated proposed rule on front-of-package (“FOP”) ...

Discover what FDA's red dye ban means for your food safety. Learn which synthetic colors remain in your favorite foods and ...

The US Food and Drug Administration announced this month that it's effectively banning Red No. 3, the controversial artificial red dye found in food and drinks that's been linked to cancer. The ...

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 14, 2025. This NDA acceptance represents a pivotal milestone for Corstasis Therapeutics, signifying the ...

LCDR Mary Kremzner, Pharm.D., is Deputy Director, Division of Drug Information, Office of Training and Communications, Center for Drug Evaluation and Research, FDA.