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.
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 shares jump 19% in premarket trading after FDA approves Nereus, the first new motion sickness treatment in 40 years.
Vanda Pharmaceuticals files FDA application for imsidolimab, a promising new treatment for generalized pustular psoriasis, with potential approval by mid-2026.
The FDA has lifted a study restriction on Vanda Pharmaceuticals' Tradipitant, potentially making it the first new motion sickness drug in decades.
Vanda Pharmaceuticals' (VNDA) tradipitant approval delayed again as FDA extends clinical hold review while labeling issues emerge for the motion sickness treatment.
