The Magazine for Sleep Professionals
Thursday, September 10, 2026
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 […]
Nyxoah SA announced that the U.S. Food and Drug Administration (FDA) has approved the Genio system (hypoglossal nerve stimulation) for a subset of patients with moderate to severe OSA with an Apnea-Hypopnea Index (AHI) of greater than or equal to 15 and less than or equal to 65. Genio is […]
Nyxoah SA, which develops breakthrough treatment alternatives for obstructive sleep apnea (OSA) through neuromodulation, announced an update on the FDA approval process for the Genio system. On March 26, 2025, the Company announced that the U.S. Food and Drug Administration (FDA) issued an Approvable Letter regarding the Company’s Pre-Market Approval […]
Sunrise has received an additional aggregate investment of $6 million from the Alexa Fund and French healthcare investor UI-Investissement (Majycc Innovation Santé), for a total of $24 million raised this year. This news comes after a breakthrough year for Sunrise. With two FDA approvals in the United States, the renewed […]
Avadel Pharmaceuticals plc, announced that the U.S. Food & Drug Administration (FDA) has granted final approval to LUMRYZ, an extended-release formulation of sodium oxybate indicated to be taken once at bedtime for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. With final approval, LUMRYZ becomes the […]
Signifier Medical Technologies LLC (“Signifier” or the “Company”), a Boston-based medical technology company, announces the FDA approval to remove dental contraindications for eXciteOSA. This opens the door for doctors and other providers to prescribe eXciteOSA on a more widespread basis. Based on an observational study conducted by Signifier Medical, the […]
Vapotherm, Inc. announced it has received 510(k) clearance from the US Food and Drug Administration for HVT 2.0. This next-generation system is designed to provide high-velocity therapy using an integrated air source, eliminating the need for wall air or any pressurized air source. It is estimated that 50% of U.S. […]
ZOLL® Medical Corporation announced that the peer-reviewed journal Nature and Science of Sleep has published five-year results from the remedē System Post Approval Study. The data show sustained safety and efficacy of transvenous phrenic nerve stimulation for the treatment of moderate to severe central sleep apnea (CSA). The remedē® System, the only implantable device […]
Signifier Medical Technologies, an innovator in the sleep-disordered breathing market announced that eXciteOSA®, the first and only daytime intraoral neuromuscular stimulation device for treating mild obstructive sleep apnea and snoring, has been cleared by the U.S. Food and Drug Administration (FDA), giving millions of sufferers in the U.S. access to […]
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 […]
