Sarepta Therapeutics

Sarepta Therapeutics Sells Rare Pediatric Disease Priority Review Voucher for $102 Million to Boost Research and Development. Pharmtales - Latest Pharma News and Insights

Sarepta Therapeutics Sells Rare Pediatric Disease Priority Review Voucher for $102 Million to Boost Research and Development

SG Tylor

Source – Sarepta Therapeutics On July 5, 2023, Sarepta Therapeutics, a leading company in precision genetic medicine for rare diseases, ...

FDA's Peter Marks Overrides Reviewers' Rejection to Approve Sarepta's Gene Therapy for Duchenne Muscular Dystrophy

FDA’s Peter Marks Overrides Reviewers’ Rejection to Approve Sarepta’s Gene Therapy for Duchenne Muscular Dystrophy

SG Tylor

Despite the FDA review teams initially leaning against approving Sarepta’s Duchenne muscular dystrophy (DMD) gene therapy, a memo reveals that ...

Sarepta Therapeutics Makes History with FDA Approval of Elevidys, the First Gene Therapy for Duchenne Muscular Dystrophy

Sarepta Therapeutics Makes History with FDA Approval of Elevidys, the First Gene Therapy for Duchenne Muscular Dystrophy

SG Tylor

Source – Sarepta Therapeutics On June 22, 2023, Sarepta Therapeutics made an announcement regarding the accelerated approval granted by the ...

Sarepta's Breakthrough DMD Gene Treatment, Elevidys, Triumphs FDA Hurdles at $3.2M

Sarepta’s Breakthrough DMD Gene Treatment, Elevidys, Triumphs FDA Hurdles at $3.2M

SG Tylor

The speedy approval of Sarepta’s Duchenne muscular dystrophy (DMD) gene therapy has been achieved after several delays and a close ...