EU Accelerated Assessment Tracker
Executive Summary
Alnylam's European marketing authorization application for givosiran will be fast-tracked when the company files for approval. Only three of the nine accelerated assessment requests that the European Medicines Agency has processed this year have been successful. See our latest updates in the tracker below.
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EU Accelerated Assessment Tracker
Marinus’s ganaxolone has lost its accelerated assessment status mid-review at the European Medicines Agency while Roche’s glofitamab will be fast-tracked once a filing has been made.
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.
AZ Secures EU Fast-Tack Review For Nirsevimab
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.