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BioWorld - Friday, December 26, 2025
Home » Keywords » Ozawade

Items Tagged with 'Ozawade'

ARTICLES

EU flag, pills, syringe

Bluebird Bio cerebral adrenoleukodystrophy gene therapy on the brink of European approval as CHMP nods through eight applications

May 21, 2021
By Cormac Sheridan
DUBLIN – Skysona (elivaldogene autotemcel, Lenti-D), Bluebird Bio Inc.’s gene therapy for cerebral adrenoleukodystrophy, received a nod from the EMA’s Committee for Human Medicinal Products (CHMP) during its May meeting this week, paving the way for a formal European authorization in the coming weeks. It will constitute the first approval for the product. An FDA approval is some way behind – the company will not complete its BLA filing with the FDA until around midyear.
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