The U.S. Food and Drug Administration approved Vanda Pharmaceuticals’ oral drug Nereus (tradipitant), marking the first new pharmaceutical treatment for motion sickness in more than four decades. The approval was supported by three pivotal studies, including two phase III real-world trials that evaluated patients on boats, and a third supportive trial. Vanda plans a commercial launch in the coming months and reported a sharp market reaction following the decision. The lead clinical evidence centered on prevention of vomiting induced by motion; the drug targets the neurokinin-1 receptor. The FDA authorization clears the path for Vanda to move Nereus into the outpatient market for a symptom set that historically lacked new therapeutic options. Investors and hospital procurement teams will watch early launch uptake and real-world tolerability data closely. Clinicians and drug-supply stakeholders should note the regulatory precedent: the FDA accepted real-world, at-sea trial data as pivotal in this case, an example of pragmatic trial evidence shaping approval pathways.