New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, including Blueprint Medicines' Ayvakyt for treating unresectable or metastatic gastrointestinal stromal tumors. The list, which contains information dating back to January 2018, comprises brand name, generic name, company, therapeutic indication, date of marketing authorization announcement and product type (eg, medicine, vaccine, biologic).
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New medicines under evaluation at the European Medicines Agency.
An advanced immunotherapy for recurrent glioblastoma and the first biosimilar version of Lucentis for age-related macular degeneration have also been submitted for review by the European Medicines Agency for potential pan-EU authorization.
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 European Union, and updates on EU marketing authorization changes recommended by the CHMP.