Narcolepsy treatment
Sep 16, 2025
Lion TCR Secures Triple FDA Milestones with IND Clearance for Chronic Hepatitis B; Corstasis Therapeutics Wins FDA Approval for ENBUMYST Nasal Spray to Treat Edema in CHF, Liver, and Kidney Disease; Amneal Gains FDA Approval for Sodium Oxybate Oral Solution in Narcolepsy Patients with Cataplexy and Excessive Daytime Sleepiness; Greenwich LifeSciences’ GLSI-100 Granted FDA Fast Track Designation; Akeso’s Ligufalimab Granted FDA Orphan Drug Designation for Acute Myeloid Leukemia
Lion TCR Secures Triple FDA Milestones for Chronic Hepatitis B with IND Clearance of TCR-T Therapy Lion TCR announced that the FDA has cleared its Investigational New Drug (IND) application for LioCyx-M004, authorizing the initiation of phase Ib/II clinical trials in patients with chronic hepatitis B (CHB). The ...
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Aug 08, 2025
Narcolepsy Treatment Market Awakens: A Projected Boom Fueled by Emerging Therapies
Narcolepsy is a chronic neurological disorder that disrupts the brain’s ability to regulate sleep-wake cycles. Often misunderstood and underdiagnosed, it typically begins in adolescence but may remain unrecognized for years. The hallmark symptoms include Excessive Daytime Sleepiness (EDS), sudden muscle weakness, v...
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Aug 21, 2019
FDA approves Non-Controlled treatment for Excessive Daytime Sleepiness
The U.S. Food and Drug Administration has approved WAKIX (pitolisant) to treat excessive daytime sleepiness (EDS) in adult patients with narcolepsy. The Narcolepsy therapy, developed by HARMONY therapeutics, is the first and the only treatment to get approval that is not labelled as a controlled substance by the US...
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