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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.
Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that ...
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 ...
In a major win for Sarepta Therapeutics Inc., US regulators are recommending that patients who can walk be allowed to take ...
Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...
Sarepta Therapeutics’ stock was soaring Tuesday after the FDA recommended lifting the pause on the company’s Duchenne ...
In this week’s edition of InnovationRx, we look at Moderna’s use of quantum computers, a new top drug regulator at the FDA, ...
In a highly unusual move, Cambridge-based Sarepta said late Friday won’t comply with a request from the Food and Drug ...
As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm ...
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.
Over a whirlwind three weeks, Sarepta Therapeutics has faced tough safety questions around its commercial gene therapy ...
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