FDA Accepts BLA Resubmission of Cosibelimab for the Treatment of Advanced cSCC
The Dermatology Digest
JULY 26, 2024
The resubmission has been accepted as a complete response to the FDA’s December 2023 complete response letter (CRL) and the FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of December 28, 2024. The CRL did not state any concerns about the clinical data package, safety, or labeling for the approvability of cosibelimab.
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