Citius Pharmaceuticals, Inc. (CTXR), has announced that their resubmitted Biologics License Application for LYMPHIR, an IL-2-based immunotherapy for patients with relapsed or refractory cutaneous T-cell lymphoma, has been accepted by the FDA. Patients considered for this treatment have previously undergone at least one systemic therapy. The FDA has set a PDUFA goal date of August 13, 2024.
This resubmitted application comes after Citius Pharmaceuticals received a Complete Response Letter from the FDA on July 28, 2023. The company believes that it has adequately addressed both enhanced product testing and additional manufacturing controls highlighted in the letter.
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