The U.S. FDA approved Vanda’s oral tradipitant (Nereus) for preventing vomiting from motion sickness, based on three pivotal studies including two real‑world phase‑3 trials. The approval ends a decades‑long void in approved pharmacologic options for motion‑induced emesis. Markets reacted sharply: Vanda shares jumped on the news and the company plans a commercial launch in early 2026. Commercial teams should note the drug’s real‑world trial design and the regulatory precedent for approvals driven by pragmatic endpoints.