The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

FDA Commissioner Marty Makary faces declining staff morale as he remakes the agency.

Doctor Makary previously spent two decades at Johns Hopkins, where he specialized in pancreatic surgery and public policy research.

While some university projects on the Trump administration’s chopping block have been able to continue, others have stopped.

All the figurative FDA trains are running on time, according to the agency’s leader Marty Makary, M.D. | “I'm proud to report that we're on track to meet all the PDUFA targets, and that morale ...

FDA Commissioner Marty Makary reportedly tried to decline approval for a rare disease drug application from KalVista Pharmaceuticals (KALV) last week. Read more here.

Engineering students at Johns Hopkins University invented a printer for a Maryland brewery that adds braille writing to beer labels, university officials said.

Opinion How we plan to cut FDA drug approval time by months Qualifying manufacturers will be able to submit some data while clinical trials are ongoing.

Two Maryland universities are trying to join 16 others in backing Harvard University's legal battle with the Trump administration over federal funding.

Vinay Prasad is taking on several big roles at the FDA, solidifying his position as a top adviser to Commissioner Marty Makary.