The Magazine for Sleep Professionals
Friday, April 10, 2026
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 […]
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 […]
Teva Pharmaceutical Industries Ltd. announced that the FDA has approved ProAir® Digihaler™ (albuterol sulfate 117 mcg) inhalation powder, the first and only digital inhaler with built-in sensors which connects to a companion mobile application and provides inhaler use information to people with asthma and COPD. ProAir® Digihaler™ is indicated for the treatment […]
Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has extended the review period for its new drug application (NDA) for solriamfetol as a treatment to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy or obstructive sleep apnea (OSA). The updated Prescription Drug User […]
The 75 mg/0.5 mL and 150 mg/1 mL single-dose prefilled syringes are expected to be available by the end of 2018 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved 75 mg/0.5 mL and 150 […]
