Vanda Pharmaceuticals Inc. announced regulatory updates regarding its drug candidate tradipitant for the prevention of vomiting induced by motion sickness. The U.S. Food and Drug Administration (FDA) has requested, and Vanda has agreed to, a brief extension for the expedited re-review of the partial clinical hold on long-term studies, now set for completion by December 5, 2025. Additionally, the FDA's review of the New Drug Application (NDA) for tradipitant is proceeding as scheduled, with a target action date of December 30, 2025. Labeling discussions between the FDA and Vanda have formally begun following recent comments from the agency. No grant or funding involving multiple organizations was mentioned.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Vanda Pharmaceuticals Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: PH34921) on November 28, 2025, and is solely responsible for the information contained therein.