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

The US Food and Drug Administration’s top vaccine official overrode agency experts in May to recommend against the broad use ...

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

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

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

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

While there's little disagreement that speeding drug approvals would be a good thing, there are more questions than answers ...

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

But current and former agency staff, as well as medical ethics experts, say recent cuts at the FDA are already making it more ...

But a deeper look reveals that some elements of the program are so aligned with "common sense" that FDA has already been ...

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

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