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

Qualifying manufacturers will be able to submit some data while clinical trials are ongoing. Marty Makary is the commissioner ...

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

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

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

Peter Marks, who headed the FDA’s Center for Biologics Evaluation and Research before being forced to resign in March, said the agency’s new risk-based COVID-19 vaccine framework contradicts the ...

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

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

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

The FDA announced a new national priority voucher plan that aims to cut drug review times, while Headspace launches direct-to ...

Industry watchers responded mostly positively to the commissioner’s new voucher program, but worries remain over staffing cuts at the agency.