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

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

In announcing his new Commissioner's National Priority Voucher (CNPV) program, FDA Commissioner Marty Makary, MD, MPH, ...

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

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

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 ...

The Food and Drug Administration commissioner repeatedly said patients should rely on guidance from their doctors.

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

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 ...