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 ...

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 ...

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

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

An influx of illegal vapes that are appealing to children has been making its way into the U.S. from China, the head of the ...

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

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

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

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

Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that ...

The U.S. Food and Drug Administration named ex-biotech exec George Tidmarsh as its chief drug regulator. FDA Commissioner ...