New EU Approvals
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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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.
Two companies are set to learn whether the European Medicines Agency will agree that their planned EU marketing applications merit an accelerated assessment.
Patients in England with non-small cell lung cancer will be the first In Europe to be offered Amgen’s KRAS G12C inhibitor.