Tag: Orphan Drug

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Japan Grants Orphan Drug Designation to Eisai’s Novel Orexin Agonist for Narcolepsy

E2086, a selective orexin 2 receptor agonist, aims to address the pathophysiology of narcolepsy by activating orexinergic neurons.

FDA Grants Orphan Drug Designation to IH Drug Contender
FDA Grants Orphan Drug Designation to Pitolisant in Prader-Willi Syndrome
Harmony Gets FDA Orphan Drug Designation for Pitolisant for Idiopathic Hypersomnia
Jazz Challenges FDA on Lumryz Approval, Avadel Responds
FDA Approves Once-Nightly Treatment for Narcolepsy
Axsome Offers Updates on Sunosi and AXS-12

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KemPharm Gets FDA Orphan Drug Designation for Serdexmethylphenidate for Idiopathic Hypersomnia

The drug developer expects to initiate a phase 2 clinical trial in patients with idiopathic hypersomnia before year-end 2022 and a second trial in patients with narcolepsy in 2023.

Tag: Orphan Drug

All

Japan Grants Orphan Drug Designation to Eisai’s Novel Orexin Agonist for Narcolepsy

FDA Grants Orphan Drug Designation to IH Drug Contender

FDA Grants Orphan Drug Designation to Pitolisant in Prader-Willi Syndrome

Harmony Gets FDA Orphan Drug Designation for Pitolisant for Idiopathic Hypersomnia

Jazz Challenges FDA on Lumryz Approval, Avadel Responds

FDA Approves Once-Nightly Treatment for Narcolepsy

Axsome Offers Updates on Sunosi and AXS-12

All

KemPharm Gets FDA Orphan Drug Designation for Serdexmethylphenidate for Idiopathic Hypersomnia

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