With this new indication, pitolisant is now approved to treat excessive daytime sleepiness, cataplexy, or both, in patients aged 6 years or older with narcolepsy.

New FDA approval for Wakix (pitolisant) allows for the treatment of cataplexy in pediatric narcolepsy patients.

FDA Accepts New Drug Application and Grants Priority Review for Takeda’s Oveporexton as a Potential First-in-Class Therapy ...

Harmony Biosciences (Nasdaq: HRMY) today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for WAKIX® (pitolisant) tablets for the ...

Narcolepsy was linked to high blood pressure, hyperlipidemia, and diabetes on top of outright cardiovascular disease events in a retrospective cohort study. Notably, patients with narcolepsy started ...

The company said Tuesday that the FDA greenlit a supplemental new drug application for Wakix, a treatment for cataplexy, a narcolepsy symptom characterized by sudden muscle weakness, in pediatric ...

Axsome Therapeutics (NASDAQ:AXSM) said a long-term Phase 3 study of its drug AXS-12 for the treatment of narcolepsy with cataplexy has met its primary endpoint. The study showed AXS-12 was able to ...

Avadel Pharmaceuticals plc has published six manuscripts in a CNS Drugs supplement titled "A New Dawn in the Management of Narcolepsy," focusing on clinical management strategies, shared ...

Please provide your email address to receive an email when new articles are posted on . Patients with narcolepsy have increased cardiovascular risks, according to researchers.. Participants who ...

Aug 27 (Reuters) - Drug companies Jazz (JAZZ.O), opens new tab and Hikma (HIK.L), opens new tab must face claims that they schemed to delay a generic version of Jazz’s blockbuster narcolepsy drug ...

The "United States Narcolepsy Drugs Market to Reach US$ 2,233.56 Million by 2033 - 7.88% CAGR Driven by Novel Therapies and Better Diagnosis" report has been added to ResearchAndMarkets.com's offering ...