New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, including BioCryst's Orladeyo for the routine prevention of recurrent attacks of hereditary angioedema.
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The sponsor of what could become the EU’s first approved ophthalmic formulation of bevacizumab needs to address outstanding issues raised by the European Medicines Agency about its filing.
Janssen/Legend Biotech's ciltacabtagene autoleucel and Ipsen's palovarotene are among the latest new medicines that have been submitted for pan-EU approval.
The European Medicines Agency has added 13 new drugs to its list of products that are under review for potential pan-EU marketing approval.