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 ...

Ibogaine is illegal in the U.S., but growing evidence shows its promise treating the effects of traumatic brain injury and ...

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

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

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 ...

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

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

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

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 ...