D.C. Circuit Upholds FDA’s Denial of Fast-Track Approval for Vanda’s Stomach Drug
- December 20, 2024
The Food and Drug Administration’s (FDA’s) refusal to approve Vanda Pharmaceuticals, Inc.’s application for fast-track approval of its investigational new drug (IND) product tradipitant for treating gastroparesis, a chronic stomach condition that causes pain, nausea, and vomiting, was not arbitrary and capricious, the D.C. Circuit confirmed December 17.
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