FDA approved Takeda’s oral orexin receptor 2 agonist Orzeyful (oveporexton) for adult narcolepsy type 1, marking a first-in-class therapy targeting the underlying cause. The approval came Aug. 5 and follows China clearance on July 22, positioning Orzeyful as a new, mechanism-based option for a chronic sleep disorder. In medical devices, Freenome’s blood-based SimpleScreen lung cancer screening assay received FDA breakthrough device designation. The designation supports its proposed use in adults ages 50 to 80 with a 20 pack-year smoking history who are not already in guideline-recommended screening, with follow-up low-dose CT imaging. Elsewhere in radiopharma, FDA issued an ITM Isotope complete response letter for its ITM-11 (177Lu-edotreotide) radiotherapeutic for GEP-NETs. The CRL was tied to manufacturing issues at a third-party facility, with no concerns flagged in the data package or safety profile.