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- Replimune announces TUDRIQEV is now commercially available in the U.S. for advanced melanomaOct 2, 2026
- Replimune's melanoma drug Tudriqev may have faced another rejection after the FDA review team found prior deficiencies were not adequately addressedSep 7, 2026
- Replimune received FDA accelerated approval for TUDRIQEV in combination with nivolumab for unresectable advanced cutaneous melanoma after progression on an anti-PD-1 regimenAug 7, 2026
- Replimune reported a favorable outcome from the FDA Cellular, Tissue, and Gene Therapies Advisory Committee meeting for RP1 in advanced melanomaJul 31, 2026
- Replimune planned RP1 BLA resubmission after productive FDA discussionsMay 29, 2026