Vanda Pharmaceuticals, Inc. v. FDA — D.C. Cir. (Sep 23, 2026)

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The D.C. Circuit hears Vanda Pharmaceuticals' challenge to an FDA decision about its sleep drug, Hetlioz. The drug, also called tasimelteon, was already approved for other sleep disorders. Vanda applied to add insomnia involving difficulty falling asleep and submitted clinical studies to support that use. FDA rejected the application and denied a hearing. Its objections include long-term safety and effectiveness, evidence about older patients, and patients' own reports of improved sleep. Vanda seeks an opportunity to contest that decision at a hearing. The court's central question is whether FDA could reject the application on the written record or whether a factual dispute required a…