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

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

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

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

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

Vinay Prasad, the FDA’s freshly appointed head of vaccines, has been named chief medical and scientific officer, taking on ...

According to an internal email, the agency may be in for more consolidation in areas including human resources, ...

FDA Commissioner Marty Makary has revealed a new priority review voucher programme for new medicines deemed to be of national ...

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

US regulators, under the guidance of FDA Commissioner Marty Makary, are launching a program to accelerate drug approvals, ...

FDA Commissioner Marty Makary has told staff that Center for Biologics Evaluation and Research Director Vinay Prasad has been ...