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New EU Approvals

Executive Summary

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, including BioCryst's Orladeyo for the routine prevention of recurrent attacks of hereditary angioedema.

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New EU Approvals

The Pink Sheet's list of EU centralized approvals of new active substances has been updated two add two new products, including BioMarin’s Voxzogo (vosoritide) for treating achondroplasia in children.

EU CHMP Opinions and MAA Updates

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

New EU Filings

Vutrisiran, Alnylam’s investigational RNAi therapeutic for treating hereditary transthyretin-mediated amyloidosis in adults with polyneuropathy, is among the latest new medicines that have been submitted for review for potential pan-EU approval.

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