Vanda Pharma Announces FDA Filing of Bysanti NDA, Decision Slated For February 2026

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Vanda Pharmaceuticals Inc.

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Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced that the U.S. Food and Drug Administration (FDA) informed Vanda that the New Drug Application (NDA) for Bysanti™ (milsaperidone) has been filed, and that at this time no potential review issues have been identified. The FDA has set February 21, 2026 as the target date for decision on this application.

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