Bysanti (milsaperidone)
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Vanda Pharmaceuticals FDA Approval Dawns A New Era For Bipolar And Schizophrenia Treatment
Benzinga· 2026-02-23 14:00
Vanda Pharmaceuticals (NASDAQ:VNDA) shares are trading higher during the premarket session on Monday following the announcement of FDA approval for Bysanti (milsaperidone), a new treatment for bipolar I disorder and schizophrenia.FDA ApprovalThe FDA’s approval of Bysanti marks a significant milestone for Vanda, as it is positioned as a first-line therapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for schizophrenia in adults.Bysanti is a new chemical entity (NCE ...
VNDA Obtains FDA Nod for Motion Sickness Drug, Stock Gains
ZACKS· 2025-12-31 13:40
Key Takeaways VNDA won FDA approval for tradipitant, branded Nereus, to prevent vomiting caused by motion sickness.Vanda Pharmaceuticals said Nereus is the first new motion sickness drug in more than 40 years.VNDA shares surged 18% after hours following the approval, extending gains into pre-market trading.Vanda Pharmaceuticals, Inc. (VNDA) announced that the FDA has approved its candidate tradipitant for the prevention of vomiting induced by motion.The drug has been approved under the brand name Nereus.Tra ...