Sarepta FDA Gene Therapy Issues - Search News

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FDA, Sarepta and gene therapy

· 4d · on MSN

Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy

Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that have attracted attention from regulators.

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BioPharma Dive · 5d

5 questions on Sarepta, the FDA and a Duchenne gene therapy crisis

· 8d · on MSN

Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys

Fierce Pharma2d

FDA weighs new study requirements for Sarepta to confirm safety of gene therapy Elevidys: report

Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the ...

Fierce Biotech5d

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 ...

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