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

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

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

FDA Commissioner Marty Makary faces declining staff morale as he remakes the agency.

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

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

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

Commissioner Marty Makary and his new vaccines chief boxed longtime bureaucrats out of the recent decision to require more ...

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

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