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Home » FDA Denies BeyondSpring’s NDA for Neutropenia Indication
FDA Denies BeyondSpring’s NDA for Neutropenia Indication
The FDA has sent a complete response letter (CRL) to BeyondSpring Pharmaceuticals denying approval of the company’s new drug application (NDA) for plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia (CIN), an abnormally low white blood cell count.