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 ...

Insiders at the Food and Drug Administration are ringing alarm bells over the agency's use of an AI to fast-track drug ...

GoodRx reports that in 2025, novel drug and biosimilar approvals lag slightly behind last year, while first generic approvals ...

Mike Pence's think tank is asking the Food and Drug Administration to turn over documents related to the dangers of the ...

Doptelet and new oral sprinkle granules is approved for children one year and older with chronic immune thrombocytopenia, ...

The approval was based on data from the randomized, double-blind, placebo-controlled phase 3b AVA-PED-301 trial.

The U.S. Food and Drug Administration (FDA) has signed off on the first-ever cream specifically approved for treating chronic ...

The European Union has approved GSK's drug Blenrep to treat relapsed or treatment-resistant forms of a cancer affecting blood ...

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 ...

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The FDA has not yet withdrawn the drug's approval, however.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 ...