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Skysona FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 19, 2022.

FDA Approved: Yes (First approved September 16, 2022)
Brand name: Skysona
Generic name: elivaldogene autotemcel
Dosage form: Suspension for Intravenous Infusion
Company: Bluebird Bio, Inc.
Treatment for: Cerebral Adrenoleukodystrophy

Skysona (elivaldogene autotemcel) is a one-time gene therapy used to treat the underlying cause of cerebral adrenoleukodystrophy (CALD).

Development timeline for Skysona

Sep 18, 2022Approval FDA Approves Skysona (elivaldogene autotemcel) Gene Therapy for Early, Active Cerebral Adrenoleukodystrophy (CALD)

Further information

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