The Magazine for Sleep Professionals
Friday, August 28, 2026
Genentech, a member of the Roche Group announced that the FDA has granted Breakthrough Therapy Designation to Esbriet® (pirfenidone) for adults with unclassifiable interstitial lung disease (uILD). The designation was granted based on data from a Phase II trial, which studied the efficacy and safety of Esbriet in uILD. The study […]
Synspira Therapeutics Inc. has signed an agreement with the Cystic Fibrosis Foundation to support the development of SNSP003, Synspira’s orally delivered non-porcine enzyme replacement therapy (ERT) designed to treat Malabsorption Syndromes. Malabsorption Syndromes are a group of life-threatening disorders that result from defects in the digestion and absorption of macronutrients […]
Merck has announced that the company has received approval from the U.S. Food and Drug Administration (FDA) for an update to the prescribing information for BELSOMRA® (suvorexant) C-IV to include findings on its use for the treatment of insomnia in patients with mild-to-moderate Alzheimer’s disease. BELSOMRA is indicated for the treatment […]
Approval Based on Robust Clinical Development Program That Included Two Pivotal Trials of Nearly 2,000 Patients Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., announced the U.S. Food and Drug Administration (FDA) approved DAYVIGOTM (lemborexant) 5 mg and 10 mg for the treatment of adult patients with insomnia, characterized […]
Medical providers must be aware of adverse effects of opioid treatment Patients and medical providers should be aware that chronic opioid use can interfere with sleep by reducing sleep efficiency and increasing the risk of sleep-disordered breathing, according to a position statement from the American Academy of Sleep Medicine. […]
Circassia Pharmaceuticals Inc. announced the launch of DUAKLIR® PRESSAIR® (aclidinium bromide and formoterol fumarate) for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).1 DUAKLIR will be available in the United States on October 21st and promoted through its dedicated COPD sales force, alongside established COPD treatment TUDORZA® (aclidinium), which […]
Global biotherapeutics leader CSL Behring will host a patient-focused symposium about Alpha-1 Antitrypsin Deficiency (AATD) on Monday, 30 September, during the 29th International Congress of the European Respiratory Society (ERS) in Madrid. ERS is the largest meeting of respiratory professionals in the world and features a scientific and educational programme designed to address […]
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 […]
