Citius Pharmaceuticals Announces Acceptance Of BLA Resubmission For LYMPHIR - Quick Facts

(RTTNews) - Citius Pharmaceuticals, Inc. (CTXR) announced the FDA has accepted the resubmission of the Biologics License Application for LYMPHIR, 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. The FDA has assigned a PDUFA goal date of August 13, 2024.

The resubmission followed dialog with the FDA resulting from a Complete Response Letter received on July 28, 2023. The company believes it has addressed enhanced product testing and additional manufacturing controls noted in the letter.

For More Such Health News, visit rttnews.com.