Posted by Michael Wonder on 19 Mar 2024
Citius Pharmaceuticals announces FDA acceptance of the BLA resubmission of Lymphir (denileukin diftitox) for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma
18 March 2024 - FDA assigns Prescription Drug User Fee Act target action date of 13 August 2024
Citius Pharmaceuticals today announced that the US FDA has accepted the resubmission of the Company's biologics license application for Lymphir (denileukin diftitox), an IL-2-based immunotherapy for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma after at least one prior systemic therapy.
