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 ...

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

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

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 ...

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

Empower Pharmacy, a Houston-based compounding pharmacy, has been sanctioned by the FDA and other states in the past decade.

The FDA approved Anzupgo for the treatment of moderate to severe chronic hand eczema in adults who do not adequately respond ...

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 ...

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