The FDA has approved the New Drug Application (NDA) for zidesamtinib to treat advanced ROS1-positive NSCLC patients who have previously undergone TKI treatment. The Prescription Drug User Fee Act (PDUFA) target action date for this drug is September 18, 2026. Furthermore, an NDA submission for neladalkib, intended for the TKI pre-treated advanced ALK-positive NSCLC population, is scheduled for the first half of 2026.