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

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

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 ...

Makary and Prasad also repeat various themes repeatedly visited by Kennedy on his Make America Healthy Again (MAHA) soapbox, ...

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

Curay, the FDA’s acting top drug regulator, is stepping down from her post after serving at the agency for more than eight ...

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

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 ...