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

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

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

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

CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...

Delgocitinib is a JAK inhibitor that blocks the activation of the JAK-STAT pathway which has been shown to play a key role in the pathophysiology of chronic inflammatory skin diseases.

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

It is unclear how the Trump administration will consider affordability when reviewing a drug, as prices are usually ...

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

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 ...

The FDA has not yet withdrawn the drug's approval, however.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