The FDA moved to approve Replimune’s oncolytic viral therapy, Tudriqev (targeting melanoma), after the program had previously faced an FDA rejection and advisory committee scrutiny. The accelerated approval comes following a rapid regulatory cycle that highlights the agency’s willingness to revisit novel modalities when evidence supports meaningful benefit in a hard-to-treat setting. Separately, the FDA will convene an advisory committee meeting in September to review Grail’s cancer test after a large randomized trial missed its primary endpoint in the UK. The decision points to continued regulatory pressure on early cancer detection assays and the evidence thresholds needed for broader use. These two actions together underscore a regulator posture that is simultaneously receptive to late-breaking clinical readouts for therapeutic platforms while maintaining tight evidentiary standards for diagnostic performance and clinical utility.