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

The federal agency introduced Elsa last month, boasting about the AI tool's ability to increase efficiency at the FDA.

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

The US Food and Drug Administration (FDA) has instructed all GLP-1 drug-makers to update their warning labels to include the ...

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

Just when the future looked bleak for GSK’s Blenrep comeback in the U.S., the FDA has blessed the company's multiple myeloma ...

Kilwins Quality Confections, LLC. issued a voluntary recall for Mocha Truffles products due to possible undeclared pecans.

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

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

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