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FDA approval for Wakix (pitolisant) in pediatric patients with narcolepsy – Harmony Biosciences

Written by | 1 Jul 2024

Harmony Biosciences announced that the FDA has approved its supplemental New Drug Application (sNDA) for Wakix (pitolisant) tablets for the treatment of excessive daytime sleepiness (EDS) in pediatric… read more.

Complete Response Letter for Hetlioz (tasimelteon) for insomnia characterised by difficulty with sleep initiation – Vanda Pharma

Written by | 15 Mar 2024

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… read more.

FDA update for supplemental NDA for Hetlioz (tasimelteon) in the treatment of insomnia – Vanda Pharma

Written by | 8 Feb 2024

Vanda Pharmaceuticals Inc. announced that on February 4, 2024, it received a notification from the FDA stating that as part of its ongoing review of Vanda’s supplemental New… read more.

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