The FDA's breakthrough devices program helps the industry with faster review times, but the benefit to patients is unclear.

This article was published by IBN, a multifaceted communications organization engaged in connecting public companies to the ...

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

Qualifying manufacturers will be able to submit some data while clinical trials are ongoing. Marty Makary is the commissioner ...

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

The FDA’s clunky launch of Elsa, an AI tool to increase efficiency, has sparked concern from agency employees and outside ...

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

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

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

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

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

FDA Commissioner Dr Marty Makary tried to allay industry concerns about recent cuts and outlined his agenda for the future.