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.

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

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

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

All the figurative FDA trains are running on time, according to the agency’s leader Marty Makary, M.D. | “I'm proud to report ...

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 ...

The Food and Drug Administration says it will begin offering faster reviews to new medicines that align with Trump ...

The FDA has expanded warnings on COVID-19 vaccines, citing rare cases of heart inflammation, particularly in young males, and ...

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

And offering a fast-track to approve drugs the Trump administration views as a priority. Welcome to the new Food and Drug ...

The Food and Drug Administration department of the US has updated its warning about rare heart risk associated with to ...