New Filings At The EMA
Executive Summary
New medicines under evaluation at the European Medicines Agency.
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Eight New Filings At EMA: Three Granted Fast Track Status
New EU marketing applications from Novimmune, Theratechnologies/TaiMed Biologics and Loxo Oncology have all been granted accelerated assessment by the European Medicines Agency.
Outlook Turns To Marketing Strategy After Scoring EU First For Ophthalmic Bevacizumab
Outlook Therapeutics’ intravitreally injected Lytenava has won the thumbs up from the European Medicines Agency. The company is assessing both direct commercialization of the product and partnering in Europe on a country-by-country basis.
EU CHMP Opinions And MAA Updates
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.