EU Accelerated Assessment Tracker
Executive Summary
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.
You may also be interested in...
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.
SIFI Among EU Fast-Track Hopefuls With ‘World’s First’ Drug For Parasitic Eye Infection
SIFI is set to learn whether the European Medicines Agency will agree that its planned EU marketing application for Akantior merits an accelerated assessment, as is Janssen for its combination treatment for prostate cancer.
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.