The Magazine for Sleep Professionals
Wednesday, September 9, 2026
Harmony Biosciences, LLC (Harmony) announced yesterday that FDA approved WAKIX®(pitolisant) for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy. WAKIX is the first and only treatment approved for patients with narcolepsy that is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration (DEA). […]
Two drugs to reduce the scarring of the lungs that occurs in patients with idiopathic pulmonary fibrosis (IPF) appear to increase longevity and decrease hospitalizations, according to new research published online in the American Thoracic Society’s American Journal of Respiratory and Critical Care Medicine. In “Clinical Effectiveness of the Anti-Fibrotic Medications […]
DicernaTM Pharmaceuticals, Inc. has announced it submitted a Clinical Trial Authorization (CTA) application to the Swedish Medical Products Agency (MPA) last week to conduct a first-in-human Phase 1/2 study of DCR-A1AT, an investigational therapy from the Company’s GalXC™ technology platform, for the treatment of alpha-1 antitrypsin (A1AT) deficiency-associated liver disease. A1AT […]
The Food and Drug Administration (FDA) is advising that rare but serious injuries have happened with certain common prescription insomnia medicines because of sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake. These complex sleep behaviors have also resulted in deaths. These behaviors appear […]
Global biotherapeutics leader CSL Behring announced that the US Food and Drug Administration (FDA) has approved 4- and 5-gram vial sizes for ZEMAIRA® [Alpha1-Proteinase Inhibitor (Human)], its therapy for treating Alpha 1 Antitrypsin Deficiency (Alpha 1). This approval is significant for the Alpha 1 community as ZEMAIRA was previously available only in […]
Label Updated to Include Reduction in Exacerbations and Major Adverse Cardiovascular Event Safety Data in Cardiovascular-Risk COPD Patients Circassia Pharmaceuticals Inc. (“Circassia” or “the Company”), recently announced that the US Food and Drug Administration (FDA) added new data to the TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) Prescribing Information that includes data from […]
Sunosi is the first and only dual-acting dopamine and norepinephrine reuptake inhibitor approved by the FDA to improve wakefulness in adults living with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) approved Sunosi™ (solriamfetol) to improve wakefulness in adult patients […]
The FDA has approved the first generic of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) for the twice-daily treatment of asthma in patients aged four years and older and maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). Mylan obtained approval to […]
Eisai Co., Ltd. and Purdue Pharma L.P. recently announced the publication of a Phase 1 safety study evaluating the impact of bedtime administration with lemborexant on driving performance the following morning. The study, which met its primary endpoint, showed no statistically significant next-day impairment of driving performance in healthy adult and […]
Cook Medical and Zelegent, Inc. announced an agreement to enhance treatment options for patients suffering from snoring. Working together, the two companies will market Zelegent’s new minimally invasive technology for snoring. The Elevo® Kit Snoring Intervention Device allows physicians to perform Elevoplasty® in an office-based setting with no general anesthesia. Headquartered in […]
