New Filings At The EMA
New medicines under evaluation at the European Medicines Agency.
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Potential treatments from BeiGene, AstraZeneca, Bayer and Cancer Prevention Pharmaceuticals are under review at the European Medicines Agency.
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.
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.