Supreme Court Rejects Review of FDA Denial of Vanda Stomach Drug

The US Supreme Court on Monday rejected to review whether the FDA properly denied Vanda Pharmaceuticals Inc.'s application for an expedited review process for its stomach drug tradipitant.

The high court’s denial upholds a lower court’s decision that the Food and Drug Administration lawfully determined that Vanda’s gastroparesis drug didn’t qualify for fast-track approval because the company couldn’t demonstrate that the treatment addressed an unmet need.

The US Court of Appeals for the District of Columbia Circuit ruled in December 2024 that the agency considered all available evidence and lived up to its statutory mandate in denying the company’s request ...