FDA Approvals, In Brief: Novartis’ Meningitis Vaccine Bexsero Gets Early Nod
This article was originally published in The Pink Sheet Daily
Also, Rockwell’s iron deficiency treatment Triferic gains agency approval, but without a dose-sparing claim related to erythropoiesis-stimulating agents; Symplmed’s perindopril/amlodipine fixed-dose combination approved for hypertension.
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The latest drug development news and highlights from our US FDA Performance Tracker.
Rockwell Medical has filed an NDA for the iron replacement therapy, which will be positioned as an alternative to I.V. iron during dialysis and could limit the need for erythropoietin-stimulating agents.
FDA Cancer Center’s New ‘Projects’ Focus On Early Endpoints; Asian American, Native Hawaiian Populations
Launched in 2023, Project Endpoint focuses on advancing understanding of early, novel endpoints, while Project ASIATICA aims to bring greater awareness of challenges and health disparities faced by Asian American, Native Hawaiian, and Other Pacific Islander patients with cancer.