U.S. Food and Drug Administration PDUFA dates on the calendar for July include an NDA review for Jazz Pharmaceuticals’ experimental medicine for cataplexy.
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.
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.
Harmony Biosciences snagged approval from the U.S. FDA for the company’s first commercial product, a treatment for narcolepsy.
A U.S. appeals court ruled invalid patents owned by Jazz Pharmaceuticals covering the company’ narcolepsy drug Xyrem, opening the door for Amneal Pharmaceuticals to launch a generic version of the medicine.
Startup Harmony Biosciences spun out of France-based Paragon Biosciences with $270 million in financing and the exclusive U.S. rights to narcolepsy drug pitolisant.
206 million American adults struggling to get a good night’s rest seek out sleep management solutions to deal with conditions such as insomnia, sleep apnea, narcolepsy, and more.
The U.S. Food and Drug Administration approved the first generic version of Xyrem, Jazz Pharmaceuticals Plc’s drug to treat patients with narcolepsy, a kind of sleeping disorder.
Scientists investigating why a GlaxoSmithKline flu vaccine triggered narcolepsy in some people say they have the first solid evidence the rare sleep disorder may be a so-called “hit-and-run” autoimmune disease. The researchers were trying to find out why, of two different flu vaccines widely deployed during the 2009/2010 swine flu pandemic, only one — GSK’s […]