New Filings At The EMA
New medicines under evaluation at the European Medicines Agency.
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A number of new products have been submitted for review at the European Medicines Agency. While marketing authorization applications from ViiV Healthcare and BioMarin Pharmaceutical are being fast-tracked, a submission from Incyte is not.
The European Medicines Agency says that Shionogi’s novel antibiotic, Fetcroja, should be approved for use across Europe but that Lilly's migraine drug, Emgality, should not be authorized for the extended indication of episodic cluster headache.
Three companies are set to learn this week whether the European Medicines Agency will fast track its review of their soon-to-be-filed EU marketing applications.