8 January 2025 - Vanda Pharmaceuticals letter to FDA Commissioner highlights faulty gastroparesis NDA review.

As previously reported, Vanda has sought approval from the US FDA for tradipitant for the treatment of patients with gastroparesis. FDA declined to approve Vanda's new drug application for tradipitant for the treatment of symptoms of gastroparesis, providing Vanda with a complete response letter on 18 September 2024.

Read Vanda Pharmaceuticals press release