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

But three of those FDA employees told CNN that Elsa just makes up nonexistent studies, something commonly referred to in AI ...

D r. James H. Bekker made it clear while standing at a podium in front of the U.S. Food and Drug Administration (FDA) in ...

The Food and Drug Administration won’t sign off on Sarepta Therapeutics Inc. bringing its controversial gene therapy back to ...

On Monday morning, the FDA hosted a 10-person expert panel on the use during pregnancy of SSRIs, which include medications ...

The U.S. Food and Drug Administration has extended its review of GSK's blood cancer drug, Blenrep, as a combination treatment ...

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

The FDA's assessment of the bread recall has designated it as a Class II risk, which means the product "may cause temporary ...

It noted that, at the time, there were products "that were represented as jams containing fruit, but the products contained ...

Mushrooms sold across two states have been recalled over fears they could be harboring listeria, a bug that "can cause ...

The U.S. Food and Drug Administration said on Monday it has appointed George Tidmarsh, a seasoned biotech executive and ...

FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s ...