FDA Pushes Back Decision Date on TG Therapeutics’ Ublituximab for RMS

The FDA has pushed back its Prescription Drug User Fee Act (PDUFA) decision date on TG Therapeutics’ Biologics License Application (BLA) for ublituximab for patients with relapsing forms of multiple sclerosis (RMS) by three months to Dec. 28.

The company said the reason for the delay is that the agency needs more time to assess a “summary of certain clinical information” in connection with what the FDA deemed to be a major amendment in the BLA submission.

The company will continue to work with the FDA to complete the review of the BLA and will be “ready to launch upon approval,” said TG Therapeutics CEO Michael S. Weiss.