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Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...
The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb girdle ...
A standoff over Elevidys could have major consequences for Duchenne patients, gene therapy companies and the perception of ...
Why: Rosen Law Firm, a global investor rights law firm, announces the filing of a class action lawsuit on behalf of purchasers of securities of Sarepta Therapeutics, Inc. (NASDAQ: SRPT) between ...
As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm ...
FDA evaluating further regulatory actions after deaths Elevidys is the only gene therapy for Duchenne muscular dystrophy Sarepta suggested updating Elevidys' label June 24 (Reuters) - The U.S ...
Both patients were teenage boys who passed away after developing acute liver failure within two months after treatment with Sarepta’s one-time therapy.
Sarepta faces competition in the gene therapy space from companies like Avidity Biosciences and Dyne Therapeutics, which are developing their own approaches to treating muscular dystrophies.
In June, Sarepta reported a second death in a patient who had received its gene therapy, which raised concerns about the safety and future demand for the treatment. Both boys were non-ambulatory ...
In June, Sarepta reported a second death in a patient who had received its gene therapy, which raised concerns about the safety and future demand for the treatment.
The FDA is investigating two deaths in non-ambulatory Duchenne muscular dystrophy patients who received a Sarepta gene therapy ...
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