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 ...

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

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 ...

Replimune's RP1 treatment for advanced melanoma faces FDA rejection due to trial design issues, despite promising results ...

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

The FDA is now fast-tracking new drug approvals — why that’s so worrying By . Marc Lallanilla. Published Aug. 24, 2023. Updated Aug. 24, 2023, 6:38 p.m. ET. Explore More ...

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

Pro-life medical groups are urging Health and Human Services Secretary Robert Kennedy Jr. to reexamine the FDA’s broad ...

The FDA has not yet withdrawn the drug's approval, however. "The FDA was experiencing trying to withdraw a drug which had failed — not just a confirmatory trial, but multiple other studies ...

These changes will have knock-on impacts far beyond US borders, because regulators in many other countries expedite review of FDA-approved drugs. The FDA becomes involved before any new drug ...