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Checkpoint Therapeutics Receives Complete Response Letter for Cosibelimab

The CRL cites findings that arose during a multi-sponsor inspection of Checkpoint’s third-party contract manufacturing organization.

Checkpoint Therapeutics, Inc. reported that the U.S. FDA has issued a complete response letter (CRL) for the cosibelimab biologic license application (BLA) for the treatment of patients with metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) who are not candidates for curative surgery or radiation. The CRL cites findings that arose during a multi-sponsor inspection of Checkpoint’s third-party contract manufacturing organization as approvability issues to address in a resu...

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