The FDA has approved Hetlioz (tasimelteon) 20mg capsules, from Vanda Pharma, for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24). Hetlioz...
Vanda Pharmaceuticals Inc.has announced that the European Commission (EC) approved Hetlioz (tasimelteon) for the treatment of non-24-hour sleep-wake disorder (Non-24)...
Vanda Pharmaceuticals announced that its MAA for oral Hetlioz capsules has been accepted for evaluation by the EMA for the...
Vanda Pharmaceuticals Inc. announced that the FDA has accepted the filing of Vanda's Supplemental New Drug Application for Hetlioz (tasimelteon)...
Vanda Pharmaceuticals Inc. announced that the FDA has approved Hetlioz (tasimelteon) capsule and liquid formulations for the treatment of adults and children, respectively, with nighttime sleep disturbances associated with Smith-Magenis Syndrome (SMS).
The FDA Peripheral and Central Nervous System Drugs Advisory Committee voted overwhelmingly to recommend the approval of Vanda's New Drug...
Vanda Pharmaceuticals Inc. announced that the FDA has accepted for priority review Vanda's applications for Smith-Magenis Syndrome (SMS).
Vanda Pharmaceuticals Inc. announced the notice of opportunity for an FDA hearing on Vanda's Supplemental New Drug Application (sNDA) for Hetlioz (tasimelteon) to treat jet lag disorder
Vanda Pharmaceuticals Inc. announced that it received a notification from the FDA stating that as part of its ongoing review...