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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 appoints George Tidmarsh as top drug regulator
The U.S. Food and Drug Administration said on Monday it has appointed George Tidmarsh, a seasoned biotech executive and ...
Managed Healthcare Executive1d
FDA Delays Approval of Replimune’s Melanoma Therapy Despite Promising Trial Results
Replimune's RP1 treatment for advanced melanoma faces FDA rejection due to trial design issues, despite promising results ...
FDA appoints biotech executive as top drug regulator under RFK Jr.
Food and Drug Administration commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the agency’s ...
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 ...
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The FDA has not yet withdrawn the drug's approval, however.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 ...
The Washington Post1y
FDA approves Eli Lilly Alzheimer’s drug after months of delay
FDA approves Eli Lilly Alzheimer’s drug after months of delay. The agency determined that the potential of slowing the devastating disease in patients with mild cognitive impairment outweigh the ...