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

The FDA announced a new national priority voucher plan that aims to cut drug review times, while Headspace launches direct-to ...

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

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

FDA Commissioner Marty Makary has told staff that Center for Biologics Evaluation and Research Director Vinay Prasad has been ...

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

FDA launches review of trials that sent American DNA to China without full consent; NIH investigates impact of Biden-era ...

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

Speaking at BIO 2025, Makary bemoaned what he called “unnecessary steps” and “avoidable delays” in the U.S. regulatory ...

As the market for AI enabled medical devices grows, experts say there is less transparency around device approvals.

Nicole Verdun, a highly respected individual in the cell and gene therapy space, was placed on administrative leave this week ...

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