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The EU has approved the tablet formulation of Calquence for patients suffering from chronic…

Feb 22, 2023
AstraZeneca’s tablet formulation of Calquence (acalabrutinib) has been approved in the European Union (EU) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL).…
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Eterna Therapeutics and Lineage Cell Therapeutics Partner to Develop Hypoimmune Pluripotent Cell…

Feb 22, 2023
Eterna Therapeutics Inc., a preclinical-stage biotechnology company committed to realizing the potential of mRNA cell engineering to provide patients with transformational new…
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Beckley Psytech’s BPL-003, a synthetic formulation of 5-MeO-DMT (Mebufotenin), granted FDA…

Feb 22, 2023
Beckley Psytech Ltd, a private, clinical-stage biotechnology company dedicated to addressing neuropsychiatric disorders by transforming psychedelics into safe, effective and licensed…
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Vaxcyte’s VAX-24 IND Cleared by FDA for Prevention of Invasive Pneumococcal Disease in Infants

Feb 22, 2023
Vaxcyte, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s infant Investigational New Drug (IND) application for VAX-24, its lead, 24-valent…
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FDA Accepts Alnylam’s Supplemental NDA for ONPATTRO (patisiran) to Treat Cardiomyopathy in…

Feb 22, 2023
Alnylam Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s supplemental New Drug Application (sNDA) for patisiran, an…
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Pfizer’s RSV Maternal Vaccine Candidate BLA Accepted by FDA for Priority Review

Feb 22, 2023
Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for its respiratory syncytial virus (RSV) vaccine…
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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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