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

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

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

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

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

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

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

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

Curay, the FDA’s acting top drug regulator, is stepping down from her post after serving at the agency for more than eight ...

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