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In a July 9 memo, the director of the FDA's Center for Biologics Evaluation and Research contended there was not enough ...
The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...
The FDA has a new director for the Center for Drug Evaluation and Research (CDER), with biopharma industry executive George ...
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Clinical Trials Arena on MSNSarepta refuses to pull gene therapy despite FDA orderSarepta Therapeutics is refusing to pull its gene therapy Elevidys (delandistrogene moxeparvovec), despite a request from the ...
The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb girdle ...
By Zachary Stieber Contributing Writer Sarepta Therapeutics will not agree to a regulatory request to pause shipments of a ...
The leader of the U.S. FDA's division that oversees vaccines, Vinay Prasad, overruled the recommendations of his agency's staff by limiting broader use of two COVID-19 vaccines. The FDA scientists had ...
The new memos from the Food and Drug Administration show how the agency’s vaccine chief, Dr. Vinay Prasad, personally ...
FDA Commissioner Marty Makary selected Dr. Vinay Prasad, a prominent critic of COVID-19 boosters, to lead the Center for Biologics Evaluation and Research.
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