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AZ Secures EU Fast-Tack Review For Nirsevimab

First Filing Worldwide Submitted To EMA For Novel Anti-RSV Immunization For All Infants

Executive Summary

There could be a regulatory decision on AstraZeneca and Sanofi's nirsevimab in the EU in H2 as a result of the European Medicines Agency speeding up its review of the marketing application for the potential new immunization against RSV in all infants.

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New EU Filings Include Tibsovo Resubmission, Pegunigalsidase & Daprodustat

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EU Accelerated Assessment Tracker

The EU filing for AstraZeneca’s nirsevimab is being reviewed under the accelerated pathway at the European Medicines Agency. Also, Janssen should know by now whether its planned filing for Zejula plus Zytiga will get the same treatment – as should SIFI for its planned Akantior filing.

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