FDA Drug Approval Updates

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FDA Appoints Biotech Exec

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 longtime Stanford University professor, as the director of the Center for Drug Evaluation and Research.

Bloomberg on MSN · 1d

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 top drug regulator, the agency confirmed Monday.

USA Today · 1d

FDA appoints biotech veteran George Tidmarsh to lead drug evaluation division

Stanford's George Tidmarsh has authored 143 scientific papers and patents, as well as played a central role in developing seven FDA-approved drugs.

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 ...

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 ...

Zacks Investment Research on MSN20h

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 ...

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 ...

MPR20h

FDA Denies Approval of Vusolimogene Oderparepvec for Advanced Melanoma

Vusolimogene oderparepvec is a genetically modified herpes simplex type 1 virus designed to directly destroy tumors and generate an anti-tumor immune response.

Replimune: FDA Rejects Application Seeking RP1 Approval

Replimune, which was seeking approval of RP1 in combination with Bristol Myers Squibb's Opdivo for the treatment of advanced melanoma, on Tuesday said the FDA issued a so-called complete response ...

2don MSN

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 ...

dvm36018h

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 ...

15d

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 ...

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