The F.D.A.’s refusal to examine the company’s mRNA shot drew widespread criticism from doctors and was divisive within the agency.
Category: Prasad, Vinayak K
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U.S. Health Officials Defend Rejection of Moderna’s Flu Vaccine
The New York Times – Business: -
FDA Expands Covid Vaccine Inquiry to Adult Deaths
The agency claimed that 10 children’s deaths were linked to the shots, although it did not release evidence to support the assertions.
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F.D.A. Attributes 10 Children’s Deaths to Covid Vaccines
The agency’s top vaccine regulator said that a review had found that the children were likely to have died “because of” the shots. But public health experts want to examine the data.
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F.D.A. Sharply Limits Use of Drug Linked to Two Teen Deaths
A gene therapy for Duchenne muscular dystrophy caused complications to the liver, prompting a review of its use for younger patients.
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F.D.A. Drug Unit Chief Is Placed on Leave, and Cites a ‘Toxic’ Environment
The official, Dr. George F. Tidmarsh, a top regulator at the agency, said disagreements over a new program to rapidly approve medications had caused tensions with agency officials.
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F.D.A. Official Overruled Scientists on Wide Access to Covid Shots
The agency’s staff scientists pointed out how Covid was still unpredictable and posed a threat to toddlers, but the official decided to restrict shots only to children with risk factors.
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F.D.A. Approves Covid Shots With New Restrictions
The agency’s fall recommendations underscore the goals of Health Secretary Robert F. Kennedy Jr. to limit access to the vaccines, which he has long opposed.
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Top F.D.A. Official Overrode Scientists on Covid Shots
Records show that a top U.S. regulator rejected the recommendations of agency experts and limited the use of Covid vaccines.
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F.D.A. Looks to A.I. to Enhance Efficiency
With a Trump-driven reduction of nearly 2,000 employees, agency officials view artificial intelligence as a way to speed drugs to the market.