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FDA Accepts Two NDAs: Rusfertide for Polycythemia Vera, Tirabrutinib for CNS Lymphoma

Mar 02, 2026

The FDA has accepted New Drug Applications for rusfertide in polycythemia vera with Priority Review and tirabrutinib for relapsed/refractory primary CNS lymphoma under Accelerated Approval, with PDUFA dates set for Q3 2026 and December 2026 respectively.

FDA Accepts Rusfertide NDA and Grants Priority Review for Polycythemia Vera Treatment

Mar 02, 2026

The FDA has accepted the New Drug Application for rusfertide, a first-in-class hepcidin mimetic peptide for polycythemia vera, and granted Priority Review with a PDUFA goal date in the third quarter of 2026.