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

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

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

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

With reports that FDA’s AI Elsa is “confidently hallucinating” studies that don’t exist, the use of AI to streamline drug review and speed up approval is not here yet.

Biotech veteran and Stanford physician-scientist brings 30 years of translational research and regulatory experience to ...

Despite ambitions to streamline regulatory review, FDA’s Elsa platform has been prone to hallucinations, prompting internal scrutiny and questions about AI reliability and governance.

Sarepta Therapeutics faces serious FDA action after news broke of a third patient death, the FDA gets a new top drug ...

While FDA Commissioner Marty Makary emphasizes learning and humility, the FDA has systematically removed the very experience ...

Two months after laying off 20% of its staff, Korro Bio says it has not retreated from its “3-2-1” corporate strategy as it prepares to release interim clinical data on its lead candidate KRRO-110 in ...

ONGOING DRUG INVESTIGATION IN HENDERSON COUNTY LEADS TO FOUR ARRESTS, SEIZURE OF DRUGS AND FIREARM ...

Scammers know we're hearing plenty about immigration, tariffs, and drug trafficking. They've never been at a loss for ways to ...