EMA
withdrawal
· 2025-10-20
EMA Refused: Elevidys (delandistrogene moxeparvovec) — Roche Registration GmbH
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
Snippet
Status: Refused. Therapeutic area: Muscular Dystrophy, Duchenne. MAH: Roche Registration GmbH. Decision date: 24/09/2025. Orphan medicine