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FDA says no to Checkpoint’s skin cancer drug cosibelimab

December 19, 2023


Checkpoint Therapeutics’ late entry into the PD-1/PD-L1 inhibitor category, cosibelimab, just got knocked back even further after it was turned down by the FDA as a treatment for skin cancer.

A complete response letter (CRL) from the US regulator cites issues with a third-party contract manufacturer, rather than any safety, efficacy, or labelling issues with the drug, and Checkpoint has said it hopes to re-apply for approval swiftly.

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