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 ...

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

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

A deep dive into the implications of the Replimune CRL that surprised insiders and investors, the role of new leadership at ...

Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the ...

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

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

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

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

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

FDA regulators said Thursday that Juul’s studies show its e-cigarettes are less harmful for adult smokers, who can benefit ...