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

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

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

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

The Food and Drug Administration said Wednesday it has expanded existing warnings on the two leading COVID-19 vaccines about ...

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

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 ...

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

An FDA pilot program, known as the Commissioner’s Priority Voucher program, could drastically change the way pharmaceutical ...

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

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