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Plinabulin FDA Approval Status

FDA Approved: No
Generic name: plinabulin
Company: BeyondSpring Inc.
Treatment for: Neutropenia Associated with Chemotherapy

Plinabulin is a selective immunomodulating microtubule-binding agent (SIMBA) in development for use in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia (CIN).

Development timeline for plinabulin

DateArticle
Dec  1, 2021BeyondSpring Pharmaceuticals Receives Complete Response Letter from the FDA for Plinabulin New Drug Application for Prevention of Chemotherapy-Induced Neutropenia (CIN)
Jun  1, 2021BeyondSpring Announces U.S. FDA Acceptance And Priority Review Of New Drug Application For Plinabulin And G-CSF Combination For The Prevention Of Chemotherapy-Induced Neutropenia (CIN)
Oct 23, 2019BeyondSpring Enrolls First Patient in Global Phase 3 Clinical Trial with Plinabulin in combination with G-CSF to Prevent Chemotherapy-Induced Neutropenia
Dec 27, 2018BeyondSpring Announces Positive Pre-NDA Meeting with the U.S. FDA for its Lead Asset, Plinabulin
Dec  6, 2018BeyondSpring Announces Phase 3 Study 105 of its Lead Asset Plinabulin for Chemotherapy-Induced Neutropenia Meets Primary Endpoint at Interim Analysis

Further information

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