FDA rejects melanoma drug, again
The FDA has declined to approve Replimune’s biologics license application for vusolimogene oderparepvec in combination with nivolumab for adults with unresectable advanced cutaneous melanoma. The agency first rejected the application in a July 21, 2025, complete response letter and reaffirmed that decision in a second complete response letter issued April 10, after reviewing additional analyses […] The post FDA rejects melanoma drug, again appeared first on Becker's Hospital Review |...
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