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

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 ...

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

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.

Marty Makary’s stewardship of the FDA will be key to the policy success of the Make America Healthy Again movement. Photo: drew angerer/Agence France-Presse/Getty Images ...

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

Speaking at BIO 2025, Makary bemoaned what he called “unnecessary steps” and “avoidable delays” in the U.S. regulatory ...

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

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