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

Food and Drug Administration (FDA) Commissioner Marty Makary said in an interview with Politico’s Dasha Burns that the FDA will “look at the data” surrounding the abortion drug, mifepristone, ...

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

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

Clearance by the Food and Drug Administration means a Stewartville manufacturer can now sell its fecal incontinence devices in the US, after years of being limited to the European market. "It is a ...

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

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 ...

Doptelet and new oral sprinkle granules is approved for children one year and older with chronic immune thrombocytopenia, ...

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

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

Ritz peanut butter cracker sandwiches are being recalled due to the possible presence of undeclared peanuts, a major allergen ...