Sarepta Therapeutics shares snapped a three-day losing streak on Tuesday, as analysts said resumption of U.S. shipments for ...

This regulatory relief, combined with several other compelling catalysts, creates a pathway for the stock to potentially ...

Despite all the buzz around Sarepta and concerns about Elevidys, industry watchers aren’t convinced this current controversy ...

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Sarepta Therapeutics Inc.’s adventure with the Duchenne muscular dystrophy (DMD) AAV-based gene therapy Elevidys (delandistrogene moxeparvovec) continued as the firm said it would restart shipments of ...

The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety ...

FDA probes Elevidys after an 8-year-old's death in Brazil; Sarepta and Roche say the death was unrelated to gene therapy ...

HCA Healthcare raises 2025 profit forecast amidst insurance uncertainty while Centene anticipates a 2026 profitability boost ...

The U.S. Food and Drug Administration (FDA) is investigating the death of an eight-year-old boy who received Sarepta ...

Sarepta has suffered another regulatory setback after the European Medicines Agency’s (EMA’s) Committee for Medicinal ...

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

The European Medicines Agency determined testing failed to prove Elevidys’ benefit and issued a negative opinion that could ...