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Ultragenyx's MPS IIIA Gene Therapy Application Validated By EMA

Source: Nasdaq

Healthcare & BiotechRegulation & LegislationProduct Launches

Ultragenyx Pharmaceutical announced that the European Medicines Agency validated its Marketing Authorisation Application for investigational gene therapy rebisufl. The validation initiates the EMA’s formal review process and is a positive regulatory milestone, though it does not constitute marketing approval.

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