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Pozelimab (C5 Antibody) BLA for Treatment of Children and Adults with Ultra-rare CHAPLE Disease…

Feb 22, 2023
Regeneron Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for pozelimab as a…
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UK Grants Full Marketing Authorization to Karyopharm and Menarini Group’s NEXPOVIO for…

Feb 22, 2023
Karyopharm Therapeutics Inc. and the Menarini Group announced that the United Kingdom's (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) has granted full Marketing…
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FDA has granted fast track designation to Biohaven’s Taldefgrobep Alfa for the treatment of…

Feb 22, 2023
Biohaven Ltd. announced that it received Fast Track designation from the U.S. Food and Drug Administration (FDA) for taldefgrobep alfa, a novel anti-myostatin adnectin, for the…
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FDA Accepts Valneva’s Chikungunya Vaccine License Application for Priority Review

Feb 21, 2023
Valneva SE, a specialty vaccine company, today announced that the U.S. Food and Drug Administration (FDA) has completed a filing review of its Biologics License Application for…
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Clover Enters into Exclusive Agreement to Commercialize Quadrivalent Seasonal Influenza Vaccine in…

Feb 21, 2023
Clover Biopharmaceuticals, Ltd. announced that it entered into an exclusive agreement with Adimmune Corporation for Clover to distribute AdimFlu-S (QIS) in mainland China, where it is…
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First Gene Therapy for Hemophilia B, CSL’s HEMGENIX, Approved by the European Commission

Feb 21, 2023
Global biotechnology leader CSL announced that the European Commission has granted conditional marketing authorization (CMA) for HEMGENIX (etranacogene dezaparvovec), the first and only…
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Capricor Therapeutics and Nippon Shinyaku Form Partnership for CAP-1002 Distribution in Japan,…

Feb 20, 2023
Capricor Therapeutics, a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other…
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M2GEN and Zephyr AI Collaborate to Advance Cancer Treatment and Cure Discovery for Patients

Feb 20, 2023
M2GEN and Zephyr AI, Inc. announced a multi-year strategic partnership that will accelerate drug discovery and expanded use investigations for cancer treatments. This collaboration…
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SYFOVRE (Pegcetacoplan Injection) Approved by FDA as the First and Only Treatment for Leading Cause…

Feb 20, 2023
Apellis Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved SYFOVRE (pegcetacoplan injection) for the treatment of geographic atrophy (GA)…
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Teva Announces FDA Approval of AUSTEDO XR (deutetrabenazine) Extended-Release Tablets, a New…

Feb 20, 2023
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved AUSTEDOXR (deutetrabenazine)…
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