TG Therapeutics: PDUFA Date Extended to June 25

  TG Therapeutics, Inc.,   (NASDAQ: TGTX), today announced the U.S. Food and Drug Administration (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® (umbralisib) as a treatment for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

The FDA notified the Company that the updated overall survival analyses which were submitted to the FDA in February 2022, constituted a major amendment to the applications, and therefore the FDA is extending the PDUFA date to provide time for a full review of the submissions.

https://www.biospace.com/article/releases/tg-therapeutics-announces-extension-of-u-s-fda-bla-snda-pdufa-date-for-ublituximab-plus-ukoniq-u2-to-treat-patients-with-cll-and-sllfda-sets-updated-pdufa-goal-date-of-june-25-2022/