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Idorsia Pharmaceuticals Ltd: US FDA approves Ponvory (ponesimod) to treat adults with relapsing forms of multiple sclerosis

Idorsia Pharmaceuticals Ltd: US FDA approves Ponvory (ponesimod) to treat adults with relapsing forms of multiple sclerosis
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GNW: FDA accepts the new drug application for review of Idorsia s daridorexant | Newsticker

for the treatment of adult patients with insomnia •      The application includes robust data from the Phase 3 registration program, which demonstrated efficacy of daridorexant on objective and subjective sleep parameters, and an improvement in daytime functioning, while maintaining a favorable safety profile Allschwil, Switzerland - March 10, 2021 Idorsia Ltd (SIX: IDIA) today announced that the US Food and Drug Administration (FDA) has accepted the new drug application (NDA) for review of Idorsia s investigational dual orexin receptor antagonist, daridorexant, for the treatment of adult patients with insomnia. Insomnia is a common problem with approximately 25 million adults in the US who meet the diagnostic criteria. Insomnia, a condition of overactive wake signaling, is defined as a combination of dissatisfaction with sleep and a significant negative impact on daytime functioning. Dissatisfaction with sleep refers to the difficulty to initiate and/or maintain sleep on a

Idorsia Pharmaceuticals Ltd: FDA accepts the new drug application for review of Idorsia s daridorexant for the treatment of adult patients with insomnia

Idorsia Pharmaceuticals Ltd: FDA accepts the new drug application for review of Idorsia s daridorexant for the treatment of adult patients with insomnia Allschwil, Switzerland - March 10, 2021 Idorsia Ltd (SIX: IDIA) today announced that the US Food and Drug Administration (FDA) has accepted the new drug application (NDA) for review of Idorsia s investigational dual orexin receptor antagonist, daridorexant, for the treatment of adult patients with insomnia. Insomnia is a common problem with approximately 25 million adults in the US who meet the diagnostic criteria. Insomnia, a condition of overactive wake signaling, is defined as a combination of dissatisfaction with sleep and a significant negative impact on daytime functioning. Dissatisfaction with sleep refers to the difficulty to initiate and/or maintain sleep on at least three nights per week for at least three months, despite adequate opportunity to sleep.

Press Release : FDA accepts the new drug application for review of Idorsia s daridorexant for the treatment of adult patients with insomnia

Message : Required fields The application includes robust data from the Phase 3 registration program, which demonstrated efficacy of daridorexant on objective and subjective sleep parameters, and an improvement in daytime functioning, while maintaining a favorable safety profile Allschwil, Switzerland March 10, 2021 Idorsia Ltd (SIX: IDIA) today announced that the US Food and Drug Administration (FDA) has accepted the new drug application (NDA) for review of Idorsia s investigational dual orexin receptor antagonist, daridorexant, for the treatment of adult patients with insomnia. Insomnia is a common problem with approximately 25 million adults in the US who meet the diagnostic criteria. Insomnia, a condition of overactive

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