TG Therapeutics (TGTX) Issues Regulatory Update

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TG Therapeutics Provides Regulatory Update

November 30, 2021 7:30 AM EST

NEW YORK, Nov. 30, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the U.S. Food and Drug Administration (FDA) has notified the Company that it plans to host a meeting of the Oncologic Drugs Advisory Committee (ODAC) in connection with its review of the pending Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the combination of ublituximab and UKONIQ® (umbralisib) (combination referred to as U2) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

Michael S. Weiss, Chairman and Chief Executive Officer... More