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Fierce Pharma1d

Untangling Sarepta’s gene therapy fallout and a growing trust deficit

Over a whirlwind three weeks, Sarepta Therapeutics has faced tough safety questions around its commercial gene therapy ...

What's Going On With Sarepta, Capricor And Other Gene Therapy Stocks On Wednesday?

Vinay Prasad exits FDA's biologics division following pressure over Sarepta's Elevidys approval and regulatory controversies.
BioPharma Dive15d

Sarepta reports patient death in limb-girdle trial, compounding concerns on gene therapy risks

The death of a 51-year-old man in the study follows two other deaths of Duchenne patients treated with Sarepta’s marketed ...
Fierce Pharma2d

Vinay Prasad's exit signals FDA's probable slip toward more permissive regulation of cell and gene therapy: analyst

But this time, the unknown is hitting the industry in a different way from when Prasad was tapped to lead CBER less than ...

FDA Lifts Safety Hold On Sarepta's Muscular Dystrophy Gene Therapy—Wall Street Cheers

Sarepta stock sees upgrades and price hikes as analysts reassess Elevidys prospects following a favorable FDA development.