Vanda Pharmaceuticals Inc. announced that the FDA has accepted the filing of Vanda's Supplemental New Drug Application for Hetlioz (tasimelteon)...
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 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).
Vanda Pharmaceuticals Inc. announced that on March 4, 2024, it received a Complete Response Letter (CRL) from the FDA as part of its ongoing review of Vanda's supplemental New Drug Application (sNDA) for Hetlioz (tasimelteon) in the treatment of insomnia characterized by difficulties with sleep initiation
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 the notice of opportunity for an FDA hearing on Vanda's Supplemental New Drug Application (sNDA) for Hetlioz (tasimelteon) to treat jet lag disorder