Records show that a top U.S. regulator rejected the recommendations of agency experts and limited the use of Covid vaccines.

Makary and Center for Biologics Evaluation and Research Director Vinay Prasad unveiled a new framework in the New England ...

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

Positive data on depression treatment based on a drug related to the psychedelic DMT is breathing life into shares of ...

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

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

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

Specifically, the new warning lists the risk of myocarditis as 8 cases per 1 million people who got the 2023-2024 COVID shots ...

Peter Marks, who headed the FDA’s Center for Biologics Evaluation and Research before being forced to resign in March, said ...

The FDA plans to approve selected high-priority drug application submissions in 1 to 2 months rather than 10 to 12.

Some of us believe in civil debate and discussion, even though Drs. Vinay Prasad, Marty Makary, and Jay Bhattacharya do not.

NRX-100, a preservative-free ketamine, is also under an Abbreviated New Drug Application (“ANDA”) with a priority review ...