The Magazine for Sleep Professionals
Friday, September 18, 2026
Takeda announced that the U.S. Food and Drug Administration (FDA) approved ORZEYFUL™ (oveporexton), an oral orexin receptor 2 (OX2R) agonist, for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults.* The persistent 24-hour nature of NT1 is driven by orexin deficiency and can severely impact people’s lives. […]
Lundbeck announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Lu AH69593, the company’s lead oral orexin 2 receptor agonist and one of several investigational compounds in Lundbeck’s development portfolio for sleep-wake disorders. Lu AH69593 was discovered by Lundbeck and it is presently in […]
The FDA has issued a warning letter to BMC Medical Co., Ltd., the Beijing-based manufacturer behind the Luna and G3X lines of CPAP and APAP devices sold in the U.S. through distributor 3B Medical (doing business as React Health) of Dublin, Ohio. The letter, dated May 20, 2026, stems from […]
ProSomnus Sleep Technologies announced that the U.S. Food and Drug Administration (FDA) has granted Class II 510(k) clearance for its RPMO₂ OSA Device under the product codes DQA, LQZ, LRK, PLC, and OUG (FDA K252765). The RPMO2 OSA Device is the first theragnostic device for sleep medicine, incorporating both precision […]
Apnimed, Inc., announced that it has entered into a senior secured credit facility for up to $150 million with funds managed by HealthCare Royalty Partners (“HCRx”). The capital is expected to support commercial readiness activities and the planned U.S. launch of Apnimed’s lead product candidate, AD109, if approved by the […]
On March 25, United States District Court Judge Rebecca L. Pennell sentenced Dr. Eric Edward Haeger, age 57, of Brewster, Washington, to one year and a day in federal prison followed by a one-year term of supervised release after Haeger pleaded guilty to adulterating and misbranding medical devices with the […]
Eli Lilly and Company and Centessa Pharmaceuticals plc, a clinical-stage company developing a new class of medicines for the treatment of excessive daytime sleepiness and other neurological conditions, announced a definitive agreement for Lilly to acquire Centessa. Centessa is advancing a pipeline of orexin receptor 2 (OX2R) agonists designed to […]
LivaNova PLC announced the U.S. Food and Drug Administration (FDA) granted premarket approval (PMA) for the aura6000™ System for the treatment of adult patients with moderate to severe Obstructive Sleep Apnea (OSA). The System utilizes proximal hypoglossal nerve stimulation (p-HGNS), a differentiated neurostimulation modality, to treat OSA in patients with […]
Wearable devices and digital apps that are available to consumers are emerging as potential tools in neurological care. These include smart watches and fitness trackers to monitor heart rate, physical activity, sleep and other health factors. To provide neurologists with guidance on the use, limitations and evidence on non-U.S. Food […]
Nexalin Technology, Inc. announced continued advancement toward its planned pivotal clinical trial evaluating HALO™ Clarity for the treatment of moderate to severe insomnia, designed to support Nexalin’s planned de novo submission to the U.S. Food and Drug Administration. The study is being conducted in collaboration with Lindus Health, a full-service clinical […]
