FDA Accepts BLA Resubmission Of LYMPHIR™ (Denileukin Diftitox) For The Treatment Of Adults With R/R Cutaneous T-Cell Lymphoma
“The acceptance of the BLA resubmission reflects the completeness of our response to the enhanced product testing and additional controls highlighted by the FDA in their July 2023 CRL. No concerns relating to safety or efficacy were noted in the letter, and we remain confident in the robustness of the clinical data package included with the initial BLA submission,” stated Leonard Mazur, Chairman and CEO of Citius.
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