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News

FDA, Sarepta

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 · 19h
FDA Probes Death Of 8-Year-Old Who Received Sarepta's Elevidys
FDA probes Elevidys after an 8-year-old's death in Brazil; Sarepta and Roche say the death was unrelated to gene therapy treatment.

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BioSpace · 19h
Sarepta Denies Latest Patient Death is Elevidys-Linked as FDA Launches Probe
Fierce Pharma · 10h
FDA takes U-turn on Sarepta’s Elevidys, backing Duchenne gene therapy again in ambulatory patients
11d
Sarepta: Safety And Efficacy Flaws Undermine Gains On Restructuring News
Sarepta Therapeutics, Inc. faces setbacks with Elevidys, safety issues, and workforce cuts, raising concerns about its ...
Fierce Biotech
7d
Sarepta LGMD trials all hit by FDA hold amid newly surfaced safety concerns over gene therapy
The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb-girdle ...
BioSpace
3d
Sarepta’s Future Increasingly Uncertain as FDA Eyes New Study for Elevidys
CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...
18hon MSN
Sarepta rises 2%; Barclays downgrades to underweight on liquidity and Elevidys concerns
Sarepta Therapeutics (NASDAQ:SRPT) shares dropped sharply premarket on Monday before paring losses as Barclays revised its ...

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