News

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 ...
BioSpace2h
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 ...
Zacks Investment Research on MSN23h
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 ...
Managed Healthcare Executive18h
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 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 ...
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 ...
dvm36021h
FDA approves first generic methimazole tablet for feline hyperthyroidism
This latest approval builds on an earlier liquid formulation of generic methimazole for feline hyperthyroidism, which ...
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 ...
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 ...
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The FDA has not yet withdrawn the drug's approval, however.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 ...