Excessive Daytime Sleepiness Archives

FDA Action Alert: Jazz, ANI and Ultragenyx

Approvals, Cataplexy, Excessive Daytime Sleepiness, Fatty Acids, FDA, FDA/Regulatory, Gels, Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD), Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD), Multiple Sclerosis, Narcolepsy, New Drug Applications, PDUFA, Refusal to File letter, Rheumatoid Arthritis, Supplemental New Drug Application (sNDA), Systemic Lupus Erythematosus (SLE), Ulcerative Colitis

U.S. Food and Drug Administration PDUFA dates on the calendar for July include an NDA review for Jazz Pharmaceuticals’ experimental medicine for cataplexy.

July 20, 2020/by BioSpace

Avadel’s Once-Nightly Narcolepsy Drug Hits Three Co-Primary Endpoints in Late-Stage Trial

Cataplexy, Clinical Trials, Excessive Daytime Sleepiness, Narcolepsy, Primary Endpoints, R&D, Shares

Dublin, Ireland-based Avadel Pharma announced positive topline data from the company’s pivotal Phase III REST-ON clinical trial of FT218 for excessive daytime sleepiness and cataplexy in patients with narcolepsy.

April 27, 2020/by BioSpace

Jazz Pharma Hits Mark with Another Narcolepsy Drug

Cataplexy, Clinical Trials, Excessive Daytime Sleepiness, Narcolepsy, Neurological Disorders, R&D, Sodium

An investigational medicine in late-stage development by Jazz Pharmaceuticals hit the mark in treating cataplexy and excessive daytime sleepiness (EDS) in adults with narcolepsy.

September 26, 2019/by BioSpace

FDA Approves First Non-Controlled Substance Treatment for Narcolepsy

Approvals, Excessive Daytime Sleepiness, FDA, FDA/Regulatory, First-In-Class, Narcolepsy, Narcolepsy, Neuropeptides, Sleep Disorders

Harmony Biosciences snagged approval from the U.S. FDA for the company’s first commercial product, a treatment for narcolepsy.

August 15, 2019/by BioSpace