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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 add three new products, including Astellas Pharma/FibroGen’s Evrenzo for treating adult patients with symptomatic anemia associated with chronic kidney disease.

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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.

Roche Among EU Fast-Track Hopefuls With Lymphoma Bispecific Mosunetuzumab

Two companies are set to learn whether the European Medicines Agency will agree that their planned EU marketing applications merit an accelerated assessment.

Amgen Strikes Early-Access Deal In England For Lung Cancer Drug Lumakras

Patients in England with non-small cell lung cancer will be the first In Europe to be offered Amgen’s KRAS G12C inhibitor.

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