Tuesday, February 22, 2022

BeiGene:. FDA Accepts Application for BRUKINSA (zanubrutinib) in Chronic Lymphocytic Leukemia

 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) for BRUKINSA® (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). CLL is the most common form of adult leukemia. The Prescription Drug User Fee Act (PDUFA) target action date is October 22, 2022.

https://finance.yahoo.com/news/beigene-announces-u-fda-acceptance-120000890.html

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