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

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

The FDA expands warnings on COVID-19 vaccines regarding myocarditis risk, particularly in young males aged 12 to 24.

All the figurative FDA trains are running on time, according to the agency’s leader Marty Makary, M.D. | “I'm proud to report ...

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

The Food and Drug Administration says it will begin offering faster reviews to new medicines that align with Trump ...

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

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

And offering a fast-track to approve drugs the Trump administration views as a priority. Welcome to the new Food and Drug ...

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

FDA Commissioner Marty Makary said that one of his key priorities is to modernize the agency by streamlining the drug review ...

Vinay Prasad is taking on several big roles at the FDA, solidifying his position as a top adviser to Commissioner Marty ...