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

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

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

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

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

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

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

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

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

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

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