Third time's the charm for Replimune as melanoma drug earns FDA greenlight

The FDA approved Replimune's melanoma immunotherapy drug Tudriqev in combination with Bristol Myers Squibb’s Opdivo after previous rejections and a positive advisory committee vote, granting accelerated approval for patients with advanced melanoma progressing on PD-1 antibody therapy.

This Wire brief sits within Fusion42's coverage of Biotech, and 14 sources have reported it between 6 Aug 2026 and 10 Aug 2026.