The FDA approved Takeda’s orexin receptor 2 agonist Orzeyful (oveporexton) for adults with narcolepsy type 1, marking the first therapy in the orexin-targeting approach in the US. Takeda said two Phase 3 trials showed improvements in wakefulness and reductions in cataplexy with a favorable safety profile, and the company expects scheduling review steps before commercial launch. Separately, the FDA is set to convene an advisory committee in September to review Grail’s Galleri cancer test after a large, randomized trial failed to meet the primary endpoint. Grail’s filing and the UK trial data will be central as the agency reconsiders the test amid continuing controversy around performance and clinical utility. In oncology policy, Replimune’s Tudriqev (RP1) secured FDA accelerated approval for advanced melanoma after the agency rejected the therapy twice before. Regulators relied on a single-arm efficacy signal in combination with Bristol Myers Squibb’s Opdivo, while stressing confirmatory Phase 3 evidence is still required.