The FDA granted accelerated approval to Replimune’s oncolytic viral therapy Tudriqev (RP1) for advanced melanoma, ending a twice-rejected approval effort. The decision follows an advisory committee vote and supports use with Bristol Myers Squibb’s Opdivo in patients whose melanoma progressed after prior PD-1-based immunotherapies. Replimune’s Tudriqev-Opdivo clearance is contingent on ongoing Phase 3 confirmatory work, and FDA reviewers previously questioned trial design and response measurement clarity. Still, panelists concluded the efficacy signal was sufficient in a high-need, hard-to-treat population. Separately, Grail is preparing for an FDA advisory committee meeting tied to its Galleri multi-cancer early detection test after a large randomized trial failed to meet a primary endpoint. The upcoming review will focus on how the evidence package supports performance and intended-use claims.