Insiders at the Food and Drug Administration are ringing alarm bells over the agency's use of an AI to fast-track drug ...

Commissioner Marty Makary said in an interview with Politico’s Dasha Burns that the FDA will “look at the data” surrounding ...

Food and Drug Administration Commissioner Marty Makary said in a recent interview he has no plans to change policies ...

The agency told Bayer it needs additional time to review the non-hormonal drug, called elinzanetant. Regulators in Canada and ...

The Food and Drug Administration has closed an investigation into a listeria outbreak that killed one person and sickened 10 ...

The U.S. Food and Drug Administration has extended its review of Bayer's experimental menopause relief drug, the German ...

The U.S. drug regulator said on Friday a unit of Johnson & Johnson issued a correction for certain lots of a part related to ...

Mike Pence's think tank is asking the Food and Drug Administration to turn over documents related to the dangers of the ...

U.S. Food and Drug Administration Commissioner Marty Makary said he is focused on overhauling long-held standards and ...

The FDA may remove the warning labels on hormone replacement therapies used to treat the symptoms of menopause. Doctors say ...

The appointment of a seasoned pharmaceutical executive, George Tidmarsh, to run the FDA’s drug center underscores the ...

An unusual FDA panel on antidepressant use during pregnancy elevated clinicians and researchers who are deeply skeptical of ...