FDA Commissioner Marty Makary, M.D., has made his pick for the next director of the FDA’s Center for Drug Evaluation and ...

The Food and Drug Administration on Monday named a longtime pharmaceutical executive to run the agency's drug program, the latest in a string of leadership changes at the agency.

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...

The FDA will select at most five companies that align with national priorities, including lower drug prices and increased ...

Replimune Group Inc. shares sank to their lowest point ever after US regulators rejected a skin cancer treatment from the ...

Industry leaders are lauding proposed changes to FDA’s food program outlined in a highly-anticipated external review by the Reagan-Udall Foundation published yesterday that includes calls for a ...

Marty Makary says the FDA will plow ahead with big plans on ultra processed foods, dietary guidelines, and expedited drug and ...

While FDA Commissioner Marty Makary emphasizes learning and humility, the FDA has systematically removed the very experience ...

The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new ...

The Food and Drug Administration (FDA) can maintain its high bar for safety and efficacy, and also cut the waste and ...