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Europe Approvals Biosimilars

AstraZeneca/MSD’s Koselugo Among 14 New Hopefuls At EMA

EU Filing Of Semumetinib Coincides With US Approval

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Executive Summary

New drugs from Eli Lilly, Pfizer, Janssen, GSK, Arvelle, BioCryst, Diurnal and Myovant are also among the latest products the European Medicines Agency is evaluating for potential pan-EU approval.

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New Filings At The EMA

New medicines under evaluation at the European Medicines Agency.

EU Accelerated Assessment Tracker

GSK secured accelerated assessment for dostarlimab at the European Medicines Agency but there was no such good news for Merck/AstraZeneca's selumetinib. MYR Pharmaceuticals' bulevirtide has reverted to standard review timelines.

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