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

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

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

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

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

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 ...

An FDA pilot program, known as the Commissioner’s Priority Voucher program, could drastically change the way pharmaceutical ...

FDA Commissioner Marty Makary has told staff that Center for Biologics Evaluation and Research Director Vinay Prasad has been ...

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