New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add a new product – Vafseo, Akebia Therapeutics’ treatment for symptomatic anemia associated with chronic kidney disease in adults on chronic maintenance dialysis.
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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.
EU Marketing Setback For Ipsen’s Connective Tissue Disease Drug
The European Medicines Agency is standing by its recommendation to reject Ipsen’s EU marketing authorization application for Sohonos, for treating fibrodysplasia ossificans progressiva.
EMA Recommends Revoking EU Approval For Novartis’s Sickle Cell Disease Drug
The results of a Phase III study did not confirm the benefits previously seen with Adakveo, the European Medicines Agency said.