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

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

In announcing his new Commissioner's National Priority Voucher (CNPV) program, FDA Commissioner Marty Makary, MD, MPH, ...

U.S. health officials have expanded warnings about a rare heart side effect associated with the two leading COVID-19 vaccines ...

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

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

Mike Davis previously worked as clinical team leader at the FDA’s Division of Psychiatry before serving as chief medical ...

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

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

Peter Marks, who headed the FDA’s Center for Biologics Evaluation and Research before being forced to resign in March, said the agency’s new risk-based COVID-19 vaccine framework contradicts the ...

In the wake of Marks' exit, FDA Commissioner Marty Makary, M.D., named Vinay Prasad, M.D., to head up the CBER. In addition to that title, Prasad recently added the title of "chief medical and science ...