FDA rejects Vanda's drug tradipitant for gastroparesis, citing additional studies needed.

The FDA has rejected Vanda Pharmaceuticals' drug tradipitant for treating gastroparesis, a condition marked by delayed gastric emptying. The agency issued a Complete Response Letter citing the need for additional studies, despite Vanda's evidence from two placebo-controlled trials. Vanda plans to pursue further approval for tradipitant and will also submit an application for its use in preventing motion sickness later this year. Vanda's shares fell 14% following the news.