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

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

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 ...

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

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 said Wednesday it has expanded existing warnings on the two leading COVID-19 vaccines about ...

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 ...

FDA Commissioner Marty Makary said that one of his key priorities is to modernize the agency by streamlining the drug review ...

“Using a common-sense approach, the national priority review program will allow companies to submit the lion’s share of the ...

According to an internal email, the agency may be in for more consolidation in areas including human resources, ...