Posted by Michael Wonder on 25 May 2021
TG Therapeutics announces FDA acceptance of biologics license application for ublituximab in combination with Ukoniq (umbralisib) as a treatment for patients with chronic lymphocytic leukaemia and small lymphocytic lymphoma
25 May 2021 - Prescription Drug User Fee Act goal date of 25 March 2022.
TG Therapeutics announced today that the U.S. FDA has accepted the biologics license application for ublituximab, the Company’s investigational glycoengineered anti-CD20 monoclonal antibody, in combination with Ukoniq (umbralisib), the Company’s once-daily, oral, inhibitor of PI3K delta and CK1 epsilon, as a treatment for patients with chronic lymphocytic leukaemia and small lymphocytic lymphoma.
