New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include five new products, including Roche’s Enspryng for neuromyelitis optica spectrum disorder.
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Investigational products from Ultragenyx and MinervaX secured a place on the European Medicines Agency’s priority medicines scheme this month.
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.
The Indian Pharmacopoeia Commission was the only applicant that made the grade for entry in a pilot program that was launched to assess countries that want to join the EU, US and Japan as full members of the 33-year-old Pharmacopoeial Discussion Group.