Polycythemia Vera
Sep 02, 2025
FDA Approves Eisai & Biogen’s LEQEMBI IQLIK for Maintenance Treatment of Early Alzheimer’s; Travere Therapeutics Gains FDA Nod for FILSPARI REMS Update in IgA Nephropathy; Vanda Pharmaceuticals’ VGT-1849B Granted FDA Orphan Drug Status for Polycythemia Vera; Teva Launches First FDA-Approved Generic SAXENDA for Weight Loss; Sanofi’s WAYRILZ Gets FDA Approval as First BTK Inhibitor for Immune Thrombocytopenia
FDA Approves Eisai & Biogen’s LEQEMBI IQLIK for Maintenance Treatment of Early Alzheimer’s Eisai Co., Ltd. and Biogen Inc. announced that the FDA has approved the Biologics License Application (BLA) for LEQEMBI IQLIK (lecanemab-irmb), a once-weekly 360 mg subcutaneous autoinjector designed for maintenance do...
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Aug 26, 2025
Madrigal Wins EU Approval for REZDIFFRA in MASH With Liver Fibrosis; Valneva Faces FDA License Suspension for Chikungunya Vaccine IXCHIQ; Coya Secures FDA IND Clearance for COYA 302 in ALS Treatment; Rusfertide Earns FDA Breakthrough Therapy Designation for Polycythemia Vera; Crinetics Gains FDA Orphan Drug Status for Atumelnant in Congenital Adrenal Hyperplasia
Madrigal Wins EU Approval For REZDIFFRA In MASH With Liver Fibrosis Madrigal Pharmaceuticals announced that the European Commission (EC) has granted conditional marketing authorization for REZDIFFRA, the first and only approved therapy in the European Union (EU) for adults with noncirrhotic metabolic dysfunction...
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Sep 26, 2023
LEQEMBI Intravenous Infusion Approval; Novartis’ Presented Updates on Lutathera; FDA Accepts Submission to Add PH-ILD to YUTREPIA Label; FDA Issues CRL to BLA for Pegfilgrastim-cbqv; FDA Fast Track Designation to Therpay, MWTX-003; EC Approves TEPKINLY (epcoritamab) for R/R DLBCL
Disc Medicine Receives FDA Fast Track Designation for MWTX-003 for the Treatment of Polycythemia Vera On Sept. 20, 2023, Disc Medicine, Inc. (NASDAQ: IRON) announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to MWTX-003 for the treatment of patients with Polycyt...
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