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Ublituximab FDA Approval Status

FDA Approved: No
Generic name: ublituximab
Company: TG Therapeutics, Inc.
Treatment for: Chronic Lymphocytic Leukemia

Ublituximab (TG-1101) is an investigational glycoengineered anti-CD20 monoclonal antibody in development for the treatment of non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), and relapsing forms of multiple sclerosis (RMS).

Development Timeline for ublituximab

DateArticle
Dec  1, 2020TG Therapeutics Initiates Rolling Submission of Biologics License Application to U.S. Food and Drug Administration for Ublituximab in Combination with Umbralisib as a Treatment for Patients with Chronic Lymphocytic Leukemia
May  5, 2020TG Therapeutics Announces Positive Topline Results from the UNITY-CLL Phase 3 Study Evaluating the Combination of Umbralisib and Ublituximab (U2) for the Treatment of Patients with Chronic Lymphocytic Leukemia
May  1, 2020TG Therapeutics Announces Publication of Ublituximab Phase 2 Clinical Trial Results in Multiple Sclerosis Journal

Further information

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