Harmony Biosciences announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for WAKIX® (pitolisant) tablets for the treatment of cataplexy in pediatric patients 6 years of age and older with narcolepsy. WAKIX is now the first-and-only FDA-approved non-scheduled treatment for pediatric and adult […]
Author: SleepWorld Magazine
Resmed Introduces Full Face Fabric Mask Designed for Comfort and Improved Sleep Health
Resmed, announced the launch of the AirTouch™ F30i Comfort mask in the United States, a new CPAP (continuous positive airway pressure) full face mask. With a soft, breathable1 fabric, the AirTouch F30i Comfort is designed to help more people start and stay on CPAP therapy. The AirTouch F30i Comfort reflects Resmed’s dedication […]
In November, the Percentage of Patients with a Telehealth Claim Increased Nationally and Regionally
The percentage of patients with a telehealth claim increased nationally and in every region in November 2025, according to FAIR Health’s Monthly Telehealth Regional Tracker. Nationally, that percentage increased from 14.5 percent in October to 15.0 percent in November, a 3.6 percent rise. The largest increase was in the Midwest, at 5.1 […]
Alkermes Completes Acquisition of Avadel, Accelerating Entry Into Sleep Medicine Market
Alkermes plc and Avadel Pharmaceuticals plc, announced Alkermes’ completion of its acquisition of Avadel, a commercial-stage biopharmaceutical company. The acquisition adds Avadel’s FDA-approved product, LUMRYZ®, to Alkermes’ commercial portfolio, and provides Alkermes with a commercial organization experienced in this disease state. This strategic move accelerates Alkermes’ entry into the sleep […]
Sunrise’s AI-Powered Measure of Respiratory Effort, REMOV, Better Reflects OSA Symptoms Than Traditional PSG Metrics
Sunrise Group, a pioneer in medical device innovation and sleep care, today announced a new peer-reviewed study in Nature Communications Medicine. Sunrise developed the only home sleep test with respiratory effort measurement that has been validated against esophageal pressure, the reference standard. The study reveals that REMOV, the Sunrise-specific marker […]
Louisiana Startup SleepNavigator Secures Statewide Investment to Scale Nationally
SleepNavigator Inc., a Louisiana-built medical software company addressing widespread breakdowns in U.S. sleep medicine, has raised its first round of funding from a coalition of statewide investors including Ochsner Health, Boot 64 Ventures, and New Louisiana Angel Fund 3. The investment positions the homegrown company to expand nationally at a […]
U.S. FDA Accepts New Drug Application and Grants Priority Review for Takeda’s Oveporexton (TAK-861) as a Potential First-in-Class Therapy for Narcolepsy Type 1
Takeda announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) and granted Priority Review for oveporexton (TAK-861) for the treatment of narcolepsy type 1 (NT1). Oveporexton is an investigational oral orexin receptor 2 (OX2R)-selective agonist designed to address the underlying orexin deficiency that causes […]
ZOLL Medical Appoints Eric Knudsen as New CEO
ZOLL announced today that it has appointed Eric Knudsen as its new Chief Executive Officer, effective April 1. Knudsen will succeed Jon Rennert, who served as ZOLL’s CEO for the past 10 years and will assume a new role as Executive Chairman of ZOLL’s Board of Directors. “As a global […]
AesyBite Oral Appliance Uses Biofeedback to Reduce Bruxism by 60%
Aesyra SA has announced the successful completion of its clinical investigation evaluating the efficacy and safety of AesyBite™ Active, an intelligent oral appliance designed to treat and prevent sleep bruxism through biofeedback. The clinical investigation demonstrated that AesyBite™ Active achieved a statistically significant and clinically meaningful reduction in sleep bruxism activity, exceeding the […]
Nyxoah Boosts Manufacturing Investment in Belgium to Fuel International Expansion
Nyxoah SA has announced an important investment in Belgium to further scale its manufacturing capacity to support its continued growth in the United States and international markets. In addition to its existing contract manufacturing operations in the United States, the Company will expand its manufacturing footprint in Wallonia, reflecting Nyxoah’s […]













