The FDA granted accelerated approval to Replimune’s oncolytic virus therapy Tudriqev (formerly RP1, to be used with Opdivo) for advanced melanoma, following a two-time rejection saga that included an FDA advisory committee vote and continued confirmatory testing requirements. The decision clears a new option for patients whose disease progressed after PD-1 blocking therapy, in a setting where treatment options are limited. In a separate regulatory milestone, Takeda’s oral orexin receptor 2 agonist Orzeyful (oveporexton, TAK-861) was approved for narcolepsy type 1. Takeda positioned the first-in-class mechanism as addressing underlying disease biology, supported by Phase 3 data showing improved wakefulness and reduced cataplexy. Collectively, the approvals underscore continued FDA willingness to move faster on therapies addressing unmet needs, while still anchoring decisions to ongoing confirmatory studies and safety surveillance commitments.