Excessive Daytime Sleepiness
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 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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Apr 03, 2017
Narcolepsy: Treatment options and market outlook
Narcolepsy is characterized by symptoms such as excessive daytime sleepiness, cataplexy (sudden loss of muscle control, often triggered by strong emotions) and fragmented sleep. Narcolepsy occurs throughout the world but occurrence rates vary among populations. Occurrence of Narcolepsy is estimated to be 1 in 2,000 ...
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