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Sarepta Shares Rise After Company Says It Will Resume Elevidys Shipments
But uncertainty remains around the FDA's decision-making and whether patient demand for Elevidys will remain, the analysts said. The company voluntarily paused Elevidys shipments for ambulatory patients last week after previously rejecting the FDA's request that it do so.
Vinay Prasad, a top regulator at the US Food and Drug Administration, has left the agency after a controversy over his ...
The Trump FDA tries to kill a therapy that has helped boys with a deadly diagnosis.
Vinay Prasad, M.D., has left the FDA less than three months into the role as director of the Center for Biologics Evaluation ...
In a major win for Sarepta Therapeutics Inc., US regulators are recommending that patients who can walk be allowed to take ...
In this week’s edition of InnovationRx, we look at Moderna’s use of quantum computers, a new top drug regulator at the FDA, ...
As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm ...
Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...
FDA permits use of Sarepta Therapeutics’ Duchenne therapy in younger patients after short-lived halt
The FDA said it was clearing the way for Sarepta Therapeutics to resume shipments of its gene therapy for Duchenne muscular ...
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FDA probes death of patient on Sarepta's Elevidys, partner Roche says death unrelated to therapy
The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received ...
Over a whirlwind three weeks, Sarepta Therapeutics has faced tough safety questions around its commercial gene therapy ...
Novo Nordisk tapped Maziar Mike Doustdar, its head of international operations, as its new chief executive officer and ...
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