FDA Accepts Replimune's Resubmission for Advanced Melanoma Drug Review

Replimune Group has announced that the FDA has accepted its Biologics License Application resubmission for RP1, a combination therapy for advanced melanoma. The agency has set an August 2, 2026, goal date for a decision, with an advisory committee meeting anticipated in late July. This marks a significant step towards potential accelerated approval for the treatment.