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

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

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

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 ...

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

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 ...

The new FDA voucher program aims to speed approval of drugs aligned with national health priorities. <li /> NRX-100, a preservative-free ...

The FDA expands warnings on COVID-19 vaccines regarding myocarditis risk, particularly in young males aged 12 to 24.