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EMA approval · 2026-08-04

EMA Authorised: Spinraza (nusinersen sodium) — Biogen Netherlands B.V.

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Summary

EMA authorises Spinraza (nusinersen) for spinal muscular atrophy, granted orphan medicine status with accelerated assessment.

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Diseases / indications

Drugs mentioned

  • Spinraza (nusinersen)

Snippet

Status: Authorised. Therapeutic area: Muscular Atrophy, Spinal. MAH: Biogen Netherlands B.V.. Decision date: 09/07/2026. Orphan medicine. Accelerated assessment