Vanda Pharmaceuticals challenged the Food and Drug Administration's refusal to approve its drug Hetlioz, leading to a favorable ruling by the U.S. Court of Appeals for the D.C. Circuit on August 18, 2025.
2 reports, 1 independent
Updated Jul 3
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New informationRepeats or wire copies
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What happened
Vanda Pharmaceuticals challenged the Food and Drug Administration's refusal to approve its drug Hetlioz, leading to a favorable ruling by the U.S. Court of Appeals for the D.C. Circuit on August 18, 2025.
Who's involved
What this event is mainly aboutKeep exploring
The entities involved
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Food and Drug Administration
government organization in Nonthaburi, Thailand
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Vanda Pharmaceuticals (United States)
company in Washington D.C., United States
Nothing else this week.
Related events
- FDA acceptance of NDA supports drug development.
- Eli Lilly and Novo Nordisk products are currently awaiting necessary approval from the Food and Drug Administration.
- DoMS findings informed regulatory actions taken by the Food and Drug Administration.
- Researchers from Johns Hopkins and Columbia, along with APA representatives, testified before the FDA.
Coverage
Newest first; wire copies grouped- PR NewswireIn a Major Win for Vanda, a Federal Appeals Court Overturns FDA's Order Denying Approval of Hetlioz for the Treatment of Jet Lag Disorder WASHINGTON, Aug. 18, 2025 /PRNewswire/ -- Vanda Pharmaceutica