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

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

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

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 said on Monday it has appointed George Tidmarsh, a seasoned biotech executive and ...

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

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

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

The topical JAK inhibitor is the first treatment approved specifically for adults with moderate-to-severe chronic hand eczema.

Treatments for bronchiectasis, chronic immune thrombocytopenia, fibromyalgia, Friedreich ataxia, and recurrent respiratory papillomatosis are under review.

In discussions with multiple potential animal health company partners to collaborate to bring Canalevia®, conditionally ...