BRIEF-Regeneron and Sanofi announce Kevzara license application resubmission for review by FDA
* Regeneron and Sanofi announce Kevzara® (sarilumab) Biologics License Application resubmission accepted for review by U.S. FDA
Dec 12 Idogen AB :
* The European Medicines Agency's Committee for Orphan Medicinal Products (COMP) has reached a positive decision regarding Idogen's application for orphan drug designation in Europe
* This means that the COMP has made the assessment that the application meets all the necessary criteria and they will therefore recommend that the European Commission grants Idogen a formal orphan drug designation
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