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EMA withdrawal · 2025-10-20

EMA Refused: Elevidys (delandistrogene moxeparvovec) — Roche Registration GmbH

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Summary

The European Medicines Agency refused to grant marketing authorization for Elevidys (delandistrogene moxeparvovec) from Roche Registration GmbH for Duchenne mus…

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Diseases / indications

Drugs mentioned

  • Elevidys (delandistrogene moxeparvovec)

Snippet

Status: Refused. Therapeutic area: Muscular Dystrophy, Duchenne. MAH: Roche Registration GmbH. Decision date: 24/09/2025. Orphan medicine