Posted by Michael Wonder on 03 Mar 2022
TG Therapeutics announces extension of U.S. FDA BLA/sNDA PDUFA date for ublituximab plus Ukoniq to treat patients with CLL and SLL
3 March 2022 - FDA sets updated PDUFA goal date of June 25, 2022.
TG Therapeutics today announced the U.S. FDA has extended the Prescription Drug User Fee Act goal date to 25 June 2022 for the biologics license application and supplemental new drug application for ublituximab in combination with Ukoniq (umbralisib) as a treatment for patients with chronic lymphocytic leukaemia and small lymphocytic lymphoma.
