While there's little disagreement that speeding drug approvals would be a good thing, there are more questions than answers ...

Speaking at BIO2025, rare disease leaders from Ultragenyx, Amylyx and Yale questioned the need for the new regulatory pathway ...

U.S. health officials have expanded warnings about a rare heart side effect associated with the two leading COVID-19 vaccines ...

FDA Commissioner Marty Makary’s pledge to reexamine the safety of medication abortion isn’t just pointless — it’s dangerous.

Makary and Center for Biologics Evaluation and Research Director Vinay Prasad unveiled a new framework in the New England ...

But current and former agency staff, as well as medical ethics experts, say recent cuts at the FDA are already making it more ...

Mike Davis previously worked as clinical team leader at the FDA’s Division of Psychiatry before serving as chief medical ...

FDA Commissioner Marty Makary reportedly initiated a brief request last week to decline approval of a rare disease drug ...

But a deeper look reveals that some elements of the program are so aligned with "common sense" that FDA has already been ...

And more health news stories you need to start your week.

Novo Nordisk is halting its collaboration with Hims & Hers Health over the sale of weight loss drugs, STAT says. The ...