EU Accelerated Assessment Tracker
Executive Summary
Accelerated assessment requests at the European Medicines Agency.
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New EU Market Hopefuls Await Their Fate; EMA Re-Adopting Zynteglo Opinion
Sponsors of a raft of new products will find out this week if the European Medicines Agency’s medicines evaluation committee, the CHMP, is convinced the therapies are ready for marketing.
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.