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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 ...
InnovationRx: Sarepta Blinks In Showdown With FDA
In this week’s edition of InnovationRx, we look at Moderna’s use of quantum computers, a new top drug regulator at the FDA, ...
BioSpace4h
FDA Opens Pilot Run of Commissioner Voucher Program
The FDA will select at most five companies that align with national priorities, including lower drug prices and increased ...
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 ...
Las Vegas Sun3d
Juul’s FDA approval doesn’t clear fog of e-cigarette risks, especially for teens
The Food and Drug Administration has granted permission for Juul to continue selling its e-cigarettes, offering some reprieve ...
Managed Healthcare Executive19h
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 ...
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JNJ Seeks FDA Approval for Oral Psoriasis Drug Icotrokinra
Johnson & Johnson JNJ announced that it has submitted a new drug application (NDA) to the FDA seeking approval for its ...
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 ...
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 ...
The Brighterside of News on MSN1d
Two FDA-approved cancer drugs significantly reverse Alzheimer's disease
Alzheimer’s disease remains one of medicine’s toughest challenges, affecting millions and costing trillions of dollars ...
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 ...