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 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 ...

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 ...

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

Smucker says goodbye to synthetic dyes in popular products by 2027, including jams, ice cream toppings, and Hostess snacks ...

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 ...

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 ...