New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add three new products, including Omjjara, GSK's treatment for splenomegaly or symptoms in adult myelofibrosis patients with moderate to severe anemia.
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Acoramidis, AstraZeneca/BridgeBio Pharma's investigational treatment for patients with transthyretin amyloid cardiomyopathy, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Twelve new drugs are now being reviewed for potential EU marketing approval, including Servier’s vorasidenib for IDH-mutant diffuse glioma, which the company says could become the first targeted therapy for the malignant and incurable brain tumor.
Outlook Therapeutics is hoping to secure EU marketing approval for the first ophthalmic formulation of bevacizumab.