Checkpoint Therapeutics, Inc. (CKPT) Thursday said the Food and Drug Administration or FDA has accepted its resubmission of Biologics License Application (BLA) for cosibelimab for the treatment of advanced cutaneous squamous cell carcinoma.
A decision from the regulator is expected on December 28.
In December 2023, the FDA had rejected the BLA for cosibelimab citing inspection findings at Checkpoint's third-party contract manufacturing organization as approvability issues to address in a BLA resubmission.
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