BeyondSpring (BYSI) Receives CRL from the FDA for Plinabulin NDA for Prevention of Chemotherapy-Induced Neutropenia
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BeyondSpring Pharmaceuticals Receives Complete Response Letter from the FDA for Plinabulin New Drug Application for Prevention of Chemotherapy-Induced Neutropenia (CIN)
December 1, 2021 8:00 AM ESTNEW YORK, Dec. 01, 2021 (GLOBE NEWSWIRE) -- BeyondSpring Pharmaceuticals (the Company or BeyondSpring) (NASDAQ: BYSI), a global pharmaceutical company focused on the development of cancer therapeutics, today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) seeking approval of plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia (CIN). The FDA issued the CRL to indicate that they have completed their review of the application and have determined that it cannot be... More
