⚖ Oral Arguments, with Context

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

No. 25-1105 Argued September 23, 2026 Published October 3, 2026

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 hearing. A hearing would test the evidence, not automatically approve the drug. You will hear references to Vanda One, an earlier case about using the same drug for jet lag; this is a separate application for insomnia.

Vanda Pharmaceuticals, Inc. v. FDA (No. 25-1105) — U.S. Court of Appeals for the D.C. Circuit, argued September 23, 2026.

Sources
Argument audio — U.S. Court of Appeals for the D.C. Circuit:https://media.cadc.uscourts.gov/recordings/docs/2026/09/25-1105.mp3
Argument date and counsel — D.C. Circuit official recordings:https://media.cadc.uscourts.gov/recordings/bydate/2026/9
FDA's insomnia-application objections and hearing notice — 89 Fed. Reg. 48647–48649:https://www.govinfo.gov/content/pkg/FR-2024-06-07/pdf/2024-12564.pdf
FDA's hearing-denial and refusal notice — 90 Fed. Reg. 11542:https://www.govinfo.gov/content/pkg/FR-2025-03-07/pdf/2025-03697.pdf
Vanda's application and litigation account — company-authored 2025 Form 10-K:https://www.sec.gov/Archives/edgar/data/1347178/000162828026007460/vnda-20251231.htm
Earlier jet-lag ruling, Vanda One — D.C. Circuit No. 24-1049:https://media.cadc.uscourts.gov/opinions/docs/2025/08/24-1049-2130249.pdf
Holding and dicta — D.C. Circuit, In re Grand Jury Investigation, No. 18-3052:https://media.cadc.uscourts.gov/opinions/docs/2019/02/18-3052.pdf
Holding and dicta — Sixth Circuit, Wright v. Spaulding, No. 17-4257:https://www.opn.ca6.uscourts.gov/opinions.pdf/19a0245p-06.pdf

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