Achondroplasia

• EMA approval · 2026-08-13
  EMA Authorised: Voxzogo (vosoritide) — BioMarin International Limited

  Voxzogo (vosoritide) has been authorised in the EU for achondroplasia by BioMarin International Limited.

• EMA approval · 2026-06-11
  EMA Authorised: Voxzogo (vosoritide) — BioMarin International Limited

  EMA authorises Voxzogo (vosoritide) for achondroplasia, granted orphan medicine status to BioMarin International Limited.

• EMA approval · 2025-11-18
  EMA Authorised: Voxzogo (vosoritide) — BioMarin International Limited

  The European Medicines Agency authorised Voxzogo (vosoritide) for the treatment of achondroplasia. The Marketing Authorisation Holder is Bio…

• FDA approval · 2024-11-04
  FDA Approved: VOXZOGO 0.4MG — Supplemental Application (BioMarin Pharmaceutical Inc.)

  FDA approved BioMarin’s supplemental application to add a 0.4 mg strength of VOXZOGO (vosoritide) for achondroplasia.

• FDA approval · 2023-10-20
  FDA Approved: VOXZOGO 0.4MG — Supplemental Application (BioMarin Pharmaceutical Inc.)

  FDA approves BioMarin's supplemental application for VOXZOGO 0.4 mg (vosoritide), adding a 0.4 mg dosage strength to the labeling for achond…

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• FDA approval · 2021-11-19
  FDA Approved: VOXZOGO 0.4MG — Original Application (BioMarin Pharmaceutical Inc.)

  FDA approved VOXZOGO (vosoritide) 0.4 mg under an original application from BioMarin for the treatment of achondroplasia in pediatric patien…

• EMA approval · 2021-06-25
  New treatment for people with dwarfism

  EMA announces a new treatment option for people with dwarfism, indicating regulatory approval or a positive recommendation for a therapy add…