The Magazine for Sleep Professionals
Monday, November 2, 2026
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 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 be […]
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 […]
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 […]
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 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 Act regarding […]
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 […]
As part of the U.S. Food and Drug Administration’s continued commitment to protect and promote the public health, the agency is alerting patients and healthcare providers of an emerging safety issue involving Philips Respironics’ DreamStation 2 Continuous Positive Airway Pressure (CPAP) machines used for treatment of obstructive sleep apnea. The […]
