The FDA's breakthrough devices program helps the industry with faster review times, but the benefit to patients is unclear.

Cell and gene therapy leaders say the agency’s decision to remove the Risk Evaluation and Mitigation Strategies that had been ...

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.

The FDA’s clunky launch of Elsa, an AI tool to increase efficiency, has sparked concern from agency employees and outside ...

FDA Commissioner Marty Makary reportedly initiated a brief request last week to decline approval of a rare disease drug ...

The pivotal trial for Neurogene's Rett syndrome gene therapy makes use of baseline controls and a rigorous endpoint that ...

On Tuesday, the Food and Drug Administration said that it would offer U.S. companies that support “U.S. national interests” a ...

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

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

Food and Drug Administration Commissioner Marty Makary announced that the agency intends to fast-track reviews for certain ...

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