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

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

FDA officials say the assistant is flawed, just as the Trump administration stresses AI adoption in healthcare.

For decades, the Food and Drug Administration has been notoriously tight-lipped about why it rejects drugs. It has remained ...

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

Johnson & Johnson eyes FDA nod to icotrokinra after phase III studies show strong skin clearance and safety in plaque ...

Food and Drug Administration commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the agency’s ...

The U.S. Food and Drug Administration (FDA) announced last week that it had approved a new blue food dye derived from the ...

The Food and Drug Administration is reconsidering its decision not to approve a drug that an Omaha mom says is saving her son ...

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

Officials with the Food and Drug Administration have approved the continued sales of tobacco-flavored e-cigarettes and refill ...

The FDA has rejected Replimune’s request for approval of RP1, adding the melanoma drug candidate to the list of assets to ...