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 ...

Bekker made it clear while standing at a podium in front of the U.S. Food and Drug Administration (FDA) in Silver Spring, Md.

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

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

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 ...

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 ...

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

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

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

Prefilled syringe eliminates the need to reconstitute separate vials prior to administration and simplifies the vaccine ...