Spinal Muscular Atrophy

• EMA approval · 2026-08-21
  EMA Authorised: Zolgensma (onasemnogene abeparvovec) — Novartis Europharm Limited

  EMA authorised Zolgensma (onasemnogene abeparvovec) for spinal muscular atrophy under conditional approval and orphan designation.

• EMA approval · 2026-08-20
  EMA Authorised: Zolgensma (onasemnogene abeparvovec) — Novartis Europharm Limited

  The EMA has authorised Zolgensma (onasemnogene abeparvovec) from Novartis Europharm Limited with conditional approval for spinal muscular at…

• EMA approval · 2026-08-04
  EMA Authorised: Spinraza (nusinersen sodium) — Biogen Netherlands B.V.

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

• EMA approval · 2026-06-15
  EMA Authorised: Zolgensma (onasemnogene abeparvovec) — Novartis Europharm Limited

  The EMA authorises Zolgensma (onasemnogene abeparvovec) for spinal muscular atrophy under a conditional approval as an orphan medicine.

• EMA approval · 2026-04-21
  EMA Authorised: Evrysdi (risdiplam) — Roche Registration GmbH

  The European Medicines Agency authorised Evrysdi (risdiplam) for spinal muscular atrophy with accelerated assessment. The decision date was …

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• FDA approval · 2026-03-27
  FDA Approved: SPINRAZA — Supplemental Application (Biogen Inc.)

  The FDA approved Biogen's supplemental application for Spinraza (nusinersen). This approval updates the drug's labeling and/or indication.

• EMA approval · 2026-03-11
  EMA Authorised: Spinraza (nusinersen sodium) — Biogen Netherlands B.V.

  The European Medicines Agency authorised Spinraza (nusinersen) by Biogen Netherlands B.V. for spinal muscular atrophy, with orphan medicine …

• FDA approval · 2026-02-10
  FDA Approved: EVRYSDI — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for Evrysdi (risdiplam) submitted by Genentech, Inc., under NDA 213535.

• FDA approval · 2026-01-21
  FDA Approved: EVRYSDI — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for Evrysdi (risdiplam) from Genentech, Inc.

• EMA approval · 2025-08-28
  EMA Authorised: Zolgensma (onasemnogene abeparvovec) — Novartis Europharm Limited

  The EMA authorised Zolgensma (onasemnogene abeparvovec) for spinal muscular atrophy under conditional, orphan designation, with Novartis Eur…

• FDA approval · 2025-02-11
  FDA Approved: EVRYSDI — Original Application (Genentech, Inc.)

  FDA approved Evrysdi (risdiplam) in an Original Application, establishing it as an oral treatment option for spinal muscular atrophy. The ap…

• FDA approval · 2025-02-11
  FDA Approved: EVRYSDI — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for EVRYSDI (risdiplam) from Genentech, Inc.

• FDA approval · 2024-04-10
  FDA Approved: SPINRAZA — Supplemental Application (Biogen Inc.)

  The FDA approved Biogen's supplemental application for Spinraza (nusinersen), indicating an expansion/modification to the product's labeling…

• FDA approval · 2024-02-29
  FDA Approved: EVRYSDI — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for EVRYSDI (risdiplam) from Genentech, Inc.

• FDA approval · 2023-10-03
  FDA Approved: EVRYSDI — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for EVRYSDI (risdiplam) from Genentech, Inc.

• FDA approval · 2023-02-17
  FDA Approved: SPINRAZA — Supplemental Application (Biogen Inc.)

  FDA approved a supplemental application for Spinraza (nusinersen) submitted by Biogen. This action updates the drug's labeling and may expan…

• FDA approval · 2022-05-27
  FDA Approved: EVRYSDI — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for Evrysdi (risdiplam) from Genentech, expanding the approved labeling for the drug. This actio…

• FDA approval · 2021-04-30
  FDA Approved: EVRYSDI — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for EVRYSDI (risdiplam) from Genentech, Inc.

• EMA approval · 2021-02-26
  First oral treatment for spinal muscular atrophy (SMA) recommended for approval

  The European Medicines Agency recommends approval of the first oral treatment for spinal muscular atrophy, marking a significant milestone i…

• FDA approval · 2020-08-07
  FDA Approved: EVRYSDI — Original Application (Genentech, Inc.)

  The FDA granted original approval for Evrysdi (risdiplam) from Genentech for the treatment of spinal muscular atrophy.

• FDA approval · 2020-06-16
  FDA Approved: SPINRAZA — Supplemental Application (Biogen Inc.)

  The FDA approved a supplemental application for Spinraza (nusinersen) filed by Biogen, indicating an expanded or updated labeling.

• EMA approval · 2020-03-27
  New gene therapy to treat spinal muscular atrophy (corrected)

  The EMA announces a new gene therapy for spinal muscular atrophy, marking a significant regulatory milestone for treatment of the disease.

• FDA approval · 2019-06-17
  FDA Approved: SPINRAZA — Supplemental Application (Biogen Inc.)

  FDA approved Biogen's supplemental application for Spinraza (nusinersen). Spinraza is used to treat spinal muscular atrophy.

• FDA approval · 2018-10-10
  FDA Approved: SPINRAZA — Supplemental Application (Biogen Inc.)

  The FDA approved Biogen's supplemental application for Spinraza (nusinersen).

• FDA approval · 2018-05-14
  FDA Approved: SPINRAZA — Supplemental Application (Biogen Inc.)

  The FDA approved Biogen's supplemental application for Spinraza (nusinersen), expanding/ updating its approved use.