TG Therapeutics Announces Extension of US FDA BLA/sNDA PDUFA Date for Ublituximab plus UKONIQ® (U2) to Treat Patients with CLL and SLL

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TG Therapeutics, Inc. announced the US FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date to June 25, 2022 for the Biologics License Application (BLA) and supplemental New Drug Application (sNDA) for ublituximab in combination with UKONIQ®as a treatment for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
[TG Therapeutics, Inc.]
Press Release