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Ublituximab FDA Approval Status

Last updated by Judith Stewart, BPharm on Dec 10, 2020.

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
Mar  3, 2022TG Therapeutics Announces Extension of U.S. FDA BLA/sNDA PDUFA Date for Ublituximab Plus UKONIQ® (U2) to Treat Patients with CLL and SLL
May 25, 2021TG Therapeutics Announces FDA Acceptance of Biologics License Application for Ublituximab in Combination with Ukoniq (umbralisib) as a Treatment for Patients with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Mar 29, 2021TG Therapeutics Completes Rolling Submission of Biologics License Application to the U.S. Food and Drug Administration for Ublituximab in Combination with Ukoniq (umbralisib) as a Treatment for Patients with Chronic Lymphocytic Leukemia
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
Oct 16, 2017TG Therapeutics Provides Update on FDA Meeting for TG-1101 (ublituximab) GENUINE Phase 3 Trial
Aug  1, 2017TG Therapeutics Announces Special Protocol Assessment (SPA) Agreement with the FDA for a Phase 3 Program of TG-1101 (ublituximab) for Patients with Multiple Sclerosis (MS)
Jun 26, 2017TG Therapeutics Recaps Preliminary Results from Ongoing Phase 2 Study of TG-1101 (ublituximab) in Patients with Multiple Sclerosis at the 3rd Congress of the European Academy of Neurology

Further information

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