The Magazine for Sleep Professionals
Thursday, July 23, 2026
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death Recalled Product Airway Kit containing Sheridan® Endotracheal Tubes Model numbers: Kit TC7855 Distribution Dates: November 28, 2018 to June 5, 2019 Devices Recalled in […]
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 […]
Teleflex Incorporated has announced a worldwide recall of certain lots of Hudson RCI® Sheridan® Endotracheal Tubes. The recalled products are designed for oral or nasal intubation and are indicated for airway management. The products involved in this recall are as follows: The U.S. Food and Drug Administration (FDA) has classified […]
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 […]
On September 5, 2017, Smiths Medical ASD issued a voluntary recall of 71 lots of Sterile Water and Saline for Inhalation USP Products (described in further detail below) that either lacked sufficient documentation to assure sterility or may have been susceptible to leaking. Sterile Water for Inhalation USP (350 mLand 550 mL Humidifier with […]
