The Magazine for Sleep Professionals
Saturday, June 13, 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 Product Names: Puritan Bennett 980 Series Ventilator Model Numbers: See Recall Database Entries Distribution Dates: February 23, 2017 to April 4, 2020 […]
Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Exclusivity (ODE) for Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution, for the treatment of idiopathic hypersomnia in adults, making it the second ODE for the medication following the exclusivity granted in the treatment […]
Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic treatments to address obstructive sleep apnea (OSA) and related disorders, today announced positive data across multiple endpoints from a Phase 2 randomized, double-blind, placebo-controlled, four-period, single-dose crossover factorial clinical trial (APC-003), and a 28-day open-label extension study, evaluating AD109 as […]
The national plaintiffs’ law firm Berger Montague has filed a class action lawsuit against Dutch medical equipment company Philips to protect consumers harmed by Philips’ recalled sleep apnea machines, including CPAP and BiPAP machines, and ventilators, which may increase users’ risk of cancer and pulmonary fibrosis, and cause other injuries […]
Following the company update on April 26, 2021, Royal Philips has provided an update on the recall notification* for specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component […]
Jazz Pharmaceuticals plc has announced positive results from the Phase 3 study of XywavTM (calcium, magnesium, potassium, and sodium oxybates) oral solution in adult patients with idiopathic hypersomnia, which will be presented during the Clinical Trials Plenary Session of the 2021 American Academy of Neurology (AAN) Annual Meeting. The presentation will further […]
Apnimed raised $25 million in a Series B financing led by existing investor, Morningside Ventures, and joined by new investors, Seligman Investments and Tao Capital Partners. The proceeds will support Apnimed’s ongoing development and commercialization plans. The company is advancing its lead program, AD109, an oral disease-modifying therapeutic for the […]
Apnimed, a clinical-stage pharmaceutical company focused on developing oral medicines to treat Obstructive Sleep Apnea (OSA) and related disorders, today announced that the first patient has been dosed in a Phase 2 clinical trial evaluating AD109 as a treatment for mild to moderate OSA. If successful, AD109 could offer an […]
Teva Pharmaceutical Industries Ltd. and its Cephalon unit were fined 60.5 million euros ($72 million) by the European Union for a pact that delayed sales of a cheaper version of a sleep-disorder drug. Teva received cash payments and struck beneficial commercial side deals with Cephalon that stopped it from rolling out a generic version […]
Harmony Biosciences Holdings, Inc. announced the FDA has approved WAKIX® (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy. WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled […]
