New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include three new products, including GlaxoSmithKline's Jemperli (dostarlimab), which is the first anti-PD-1 therapy approved for recurrent or advanced endometrial cancer.
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Marketing applications for 10 new drugs have been added to the latest list of products under review by the European Medicines Agency.
Applications for the accelerated assessment of planned EU marketing applications for two drugs are being considered by the European Medicines Agency.
The sponsor of an ophthalmic formulation of bevacizumab is set to speak up for its marketing authorization application during a European Medicines Agency oral explanation meeting.