News

FDA’s New Drug Approval AI Is Generating Fake Studies: Report
But three of those FDA employees told CNN that Elsa just makes up nonexistent studies, something commonly referred to in AI ...
FDA’s artificial intelligence is supposed to revolutionize drug approvals. It’s making up studies
Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...
US FDA extends review of GSK's blood cancer drug
The U.S. Food and Drug Administration has extended its review of GSK's blood cancer drug, Blenrep, as a combination treatment ...
FDA Suspends Muscular Dystrophy Drug After 3 Patient Deaths
The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...
Medical groups urge Kennedy, FDA to reexamine broad approval of abortion drugs
Pro-life medical groups are urging Health and Human Services Secretary Robert Kennedy Jr. to reexamine the FDA’s broad ...
Clinical Pain Advisor1d
FDA Drug Approval Decisions Expected in August 2025
Treatments for bronchiectasis, chronic immune thrombocytopenia, fibromyalgia, Friedreich ataxia, and recurrent respiratory papillomatosis are under review.
New York Post1y
FDA fast-tracking approval of new drugs — fewer trials, less info
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 ...
FDA to consider drug affordability when granting new vouchers to speed up approvals, Makary says
It is unclear how the Trump administration will consider affordability when reviewing a drug, as prices are usually ...
NPR2y
FDA has new leverage over companies looking for a quicker drug approval
The FDA has not yet withdrawn the drug's approval, however.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 ...
C&EN2mon
How will FDA changes reshape drug approval in 2025 and beyond?
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 ...