New Filings At The EMA
Executive Summary
New medicines under evaluation at the European Medicines Agency.
You may also be interested in...
Roche Takes Orphan Satralizumab To EMA
There are six new entries on the latest list of products under review at the European Medicines Agency – products with orphan status from Roche and Novo Nordisk and four generic or biosimilars.
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.