The Food and Drug Administration's top official overseeing drug and food safety inspections told staff on Monday he has decided to leave the agency, and multiple federal health officials told CBS ...

The FDA needs to strengthen guardrails to ensure its accelerated approval pathway is used appropriately, the HHS Office of Inspector General (OIG) said. The agency should do two things ...

On February 1, 2024, Abeona Therapeutics, Inc. (NASDAQ:ABEO) announced that, as part of the review of the Biologics License Application (BLA) for prademagene zamikeracel (pz-cel; formerly EB-101 ...

As the U.S. gatekeeper for medical tests, how should the FDA strike a balance between making sure the public has options during a national emergency and making sure those tests actually work?

In 'Wonder Drug,' Jennifer Vanderbes traces the dark history of thalidomide : NPR's Book of the Day In the 1960s, FDA inspector Frances Kelsey was assigned her first drug to review: thalidomide.

Michael Rogers had worked for the FDA for more than three decades, culminating in a role as the agency's associate commissioner for inspections and investigations. Colleagues said they were ...