Japan Grants Orphan Drug Designation to Vanda’s Imsidolimab for Rare Skin Disease GPP
Vanda’s drug imsidolimab receives orphan drug status in Japan for the rare skin disease GPP, speeding up approval.
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FDA Approves BYSANTI (Milsaperidone) for Bipolar I & Schizophrenia
Vanda Pharmaceuticals’ BYSANTI (milsaperidone) receives FDA approval as a new atypical antipsychotic for bipolar I manic/mixed episodes and schizophrenia in adults. Launch expected Q3 2026 with strong patent protection until 2044.
FDA Rejects Vanda's Hetlioz for Jet Lag—Shares Drop 12%
Vanda Pharmaceuticals stock falls in premarket trading after FDA denies Hetlioz approval for jet lag disorder, citing clinical trial design concerns despite positive efficacy data.
Vanda Pharmaceuticals Stock Soars on FDA Approval of Motion Sickness Drug
Vanda Pharmaceuticals shares jump 19% in premarket trading after FDA approves Nereus, the first new motion sickness treatment in 40 years.
Vanda Submits Application for New GPP Treatment
Vanda Pharmaceuticals files FDA application for imsidolimab, a promising new treatment for generalized pustular psoriasis, with potential approval by mid-2026.
FDA Clears Vanda's Tradipitant for Motion Sickness Studies
The FDA has lifted a study restriction on Vanda Pharmaceuticals' Tradipitant, potentially making it the first new motion sickness drug in decades.