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BioWorld - Friday, March 6, 2026
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Home » Vanda’s Hetlioz wins round against FDA over denial of hearing
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Vanda’s Hetlioz wins round against FDA over denial of hearing

Aug. 18, 2025
By Mari Serebrov
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A U.S. appeals court schooled the FDA as it handed Vanda Pharmaceuticals Inc. a “technical knockout” of sorts in yet another regulatory bout with the agency – this one over the FDA’s refusal to grant the company’s request for a hearing after it had received a complete response letter (CRL) for a jet lag supplemental indication for Hetlioz (tasimelteon).
BioWorld Regulatory Neurology/psychiatric Small molecule U.S. Courts FDA

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