《睡眠專業人士雜誌》
星期四, 七月 23, 2026
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 […]
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 […]
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 […]
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 […]
Harmony Biosciences, has announced strong preliminary, unaudited net product revenue for Q4 and full year 2025 of approximately $243 million and $868 million, respectively. The company continues to build on six consecutive years of revenue growth. On track to extend the pitolisant franchise, Harmony fortifies its profile as a profitable, […]
A new Cedars Sinai Physician Associated Study is among the largest real-world evaluations of mandibular advancement device therapy for mild to moderate obstructive sleep apnea (OSA) and one of the first to examine a fully virtual, dentist-led care model from diagnosis through treatment and follow-up. Using the processes and care […]
Idorsia Ltd announces that its novel treatment for insomnia disorder QUVIVIQ (Daridorexant) has been awarded the inaugural Prix Galien Bridges Award in the category of “Best Biotechnology & Pharmaceutical Product”. The award recognizes groundbreaking medicines, including biologics, gene therapies, and traditional pharmaceutical compounds, that advance patient care through scientific innovation. […]
All around the world, sleep specialists are facing the same reality: the burden of sleep disorders is growing. And patients increasingly need faster, more flexible access to high-quality diagnostics and treatment. In Germany, where we are based, the cost of sleep disorders has risen nearly 50% in less than a […]
對於數百萬同時患有肥胖症與阻塞性睡眠呼吸中止症（OSA）的患者而言，提爾澤帕肽（Tirzepatide，商品名 Zepbound® 及 Mounjaro®，禮來公司）或許能提供一種值得歡迎的治療方案，有助於減輕症狀並改善整體健康狀況與生活品質。自 SURMOUNT-OSA 試驗的研究人員 […] 以來，至今已將近整整一年。
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 […]
