13 February 2024 - FDA acceptance of the completed resubmission package and issuance of a Prescription Drug User Fee Act date is expected within 30 days of resubmission.
Citius Pharmaceuticals today announced the resubmission of the Company's biologics license application to the US FDA 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.