The Magazine for Sleep Professionals
Friday, August 28, 2026
DArway Management, the innovator behind TAP Sleep Care announced that its groundbreaking Nylon flexTAP® has received Pricing, Data Analysis, and Coding (PDAC) approval for HCPCS code E0486. This final approval means Airway Management is now the only oral appliance manufacturer in the United States with its entire portfolio of custom devices fully covered […]
Avadel Pharmaceuticals plc, a biopharmaceutical company focused on transforming medicines to transform lives, announced that, on Friday, June 27, 2025, the U.S. Court of Appeals for the District of Columbia Circuit (the “Appeals Court”) affirmed a prior decision of the U.S. District Court for the District of Columbia (the “District […]
Harmony Biosciences Holdings, Inc., today announced a settlement agreement with Lupin Limited, resolving the patent infringement litigation related to Lupin’s Abbreviated New Drug Application (ANDA) for a generic version of WAKIX® (pitolisant hydrochloride). As part of the agreement, litigation in the United States District Court for the District of Delaware will […]
Avadel Pharmaceuticals plc, a biopharmaceutical company focused on transforming medicines to transform lives, announced today that LUMRYZTM has been granted Orphan Drug Designation (ODD) from the U.S. Food & Drug Administration (FDA) for the treatment of Idiopathic Hypersomnia (IH). Specifically, ODD was granted based on the plausible hypothesis that LUMRYZ may […]
Axsome Therapeutics, Inc. a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that it has entered into a settlement agreement with Hetero Labs Ltd. and certain of its affiliates (Hetero) resolving patent litigation related to Axsome’s product SUNOSI® (solriamfetol). The litigation, which […]
Obstructive sleep apnea (OSA) is a complex condition with a variety of contributing anatomical, physiological, inflammatory, and obesity-related risk factors, which can lead to many physiological changes in the body.1 Yet for patients with OSA, there is good reason to be hopeful right now. We are witnessing tremendous advances in […]
Resmed announced its home sleep apnea test, NightOwl™, is now available across the United States. NightOwl is an FDA-cleared home sleep apnea test (HSAT) designed to offer healthcare providers a simplified, accurate, and efficient way to diagnose obstructive sleep apnea (OSA) from the comfort of an individual’s home. OSA, a […]
PranaQ has received U.S. Food and Drug Administration (FDA) 510(k) clearance for TipTraQ, a single-point-of-contact home sleep apnea test wearable that provides comprehensive sleep and respiratory insights with minimal sleep disruption. “Receiving FDA clearance for TipTraQ is a significant milestone in our mission to revolutionize sleep diagnostics and monitoring,” said […]
Avadel Pharmaceuticals plc , a biopharmaceutical company focused on transforming medicines to transform lives, announced that yesterday, the U.S. District Court for the District of Columbia (“Court”) ruled in favor of the Food and Drug Administration (“FDA”) in a suit brought by Jazz Pharmaceuticals Inc. (“Jazz”) under the Administrative Procedure […]
Centessa Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug application (IND) to initiate a Phase 1 first-in-human clinical trial of ORX750 for the treatment of narcolepsy. ORX750 is an investigational, orally administered, highly potent and selective orexin receptor 2 (OX2R) agonist […]
