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

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 ...

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

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

The FDA announced a new national priority voucher plan that aims to cut drug review times, while Headspace launches direct-to ...

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

FDA Commissioner Marty Makary said that one of his key priorities is to modernize the agency by streamlining the drug review ...

FDA Commissioner Dr Marty Makary tried to allay industry concerns about recent cuts and outlined his agenda for the future.

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

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

Nicole Verdun, a highly respected individual in the cell and gene therapy space, was placed on administrative leave this week ...