Citius Pharmaceuticals' LYMPHIR™ BLA resubmission for cutaneous T-cell lymphoma accepted by FDA, PDUFA goal date August 13, 2024.

Citius Pharmaceuticals' Biologics License Application (BLA) resubmission for its immunotherapy LYMPHIR™ (denileukin diftitox) for relapsed or refractory cutaneous T-cell lymphoma has been accepted by the FDA, with a Prescription Drug User Fee Act (PDUFA) goal date of August 13, 2024. The company addressed concerns from a previous Complete Response Letter, providing enhanced product testing and additional manufacturing controls.