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FDA mulls Elevidys market withdrawal following 3rd death after a Sarepta gene therapy
Although Sarepta initially appeared to have avoided the worst possible outcome for Elevidys—market withdrawal—thanks to the gene therapy’s new black box warning, the FDA is signaling stronger misgivings about the approved drug amid a third patient death from an investigational treatment.
Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.
Beyond staff cuts, the departures of some longtime investigators in recent months have left less experienced people tasked ...
Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees ...
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Sarepta Therapeutics lays off 500 employees amid FDA investigation, including 80 in ColumbusSarepta Therapeutics announced it is laying off nearly 500 employees this week, including 80 at its Easton location.
WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...
In the first 6 months of 2025, 385 employees resigned from the Center for Drug Evaluation and Research, compared with under ...
Dr. Marty Makary is known for his contrarian views and previously called the FDA “broken,” and “mired in politics” while working for Fox News.
Cuts at the FDA are slowing inspections of overseas drug manufacturers, prompting concerns from former and current employees that medication safety could be at risk, ProPublica reported July 7. Dozens ...
FDA cuts gutted key conflict of interest staff, raising concerns about transparency, advisory panel delays, and drug oversight under the new commissioner.
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