Newsroom

NEW YORK--(BUSINESS WIRE)--Rosen Law Firm, a global investor rights law firm, reminds investors that a shareholder filed a class action on behalf of purchasers of securities of Zynex, Inc. (NASDAQ: ZYXI) between March 13, 2023 and March 11, 2025. Zynex is a medical device manufacturer. For more information, submit a form, email attorney Phillip Kim, or give us a call at 866-767-3653. The Allegations: Rosen Law Firm is Investigating the Allegations that Zynex, Inc. (NASDAQ: ZYXI) Misled Investor...

MALVERN, Pa., e TOKYO--(BUSINESS WIRE)--Fujirebio oggi ha annunciato che la Food and Drug Administration (FDA) statunitense ha autorizzato la notifica pre-commercializzazione 510(k) per il test diagnostico in vitro (IVD) della società Lumipulse ® G pTau 217/β-Amyloid 1-42 Plasma Ratio per valutare la patologia amiloide in pazienti sottoposti a valutazione della malattia di Alzheimer e di altre cause di declino cognitivo. Il testo originale del presente annuncio, redatto nella lingua di partenza...

MALVERN (Pensilvania) y TOKIO--(BUSINESS WIRE)--Fujirebio anuncia que la Administración de Alimentos y Medicamentos de EE. UU. (FDA) ha concedido la autorización 510(k) para la prueba Lumipulse ® G pTau 217/β-Amyloid 1-42 Plasma Ratio de diagnóstico in-vitro (DIV) de la compañía para la evaluación de la patología amiloide en pacientes que están siendo evaluados para la enfermedad de Alzheimer y otras causas de deterioro cognitivo. La prueba, a la que la FDA ha concedido la «Breakthrough Device...

MALVERN, Pensilvânia, e TÓQUIO--(BUSINESS WIRE)--A Fujirebio anunciou hoje que a Administração de Alimentos e Medicamentos dos EUA (FDA) concedeu autorização 510(k) para o teste de diagnóstico Lumipulse ® in-vitro (IVD) G pTau 217/β-Amyloid 1-42 Plasma Ratio da empresa para a avaliação da patologia amiloide em pacientes que estão sendo avaliados para a doença de Alzheimer e outras causas de declínio cognitivo. O teste, que recebeu a designação de dispositivo inovador da FDA, é o primeiro teste...

賓夕法尼亞州瑪律文和東京--(BUSINESS WIRE)--(美國商業資訊)-- Fujirebio今日宣布，該公司的Lumipulse ® G pTau 217/β-澱粉樣蛋白1-42血漿比值體外診斷(IVD)檢測已獲美國食品藥物管理局(FDA)頒發的510(k)上市授權。該檢測用於評估阿茲海默症及其他認知功能減退病因病患的澱粉樣蛋白病變，曾獲FDA突破性器材認定，是美國第一個獲FDA核准用於輔助辨識阿茲海默症(AD)相關澱粉樣蛋白病變病患的血液IVD檢測方法。 據估計，目前約有720萬美國人受阿茲海默症影響，預期到2060年這一數字將增至近1400萬。1該疾病是導致身心障礙和死亡的主要原因之一。阿茲海默症在症狀顯現前已發展多年，但由於缺乏便捷、微創的診斷手段，許多病患直至病情晚期才被確診，此時有效介入措施已極為有限。 Lumipulse G pTau 217/β澱粉樣蛋白1-42血漿比值檢測透過精準、微創、便捷的方式測量血漿中pTau 217和β-澱粉樣蛋白1-42的濃度，以此做為大腦β-澱粉樣蛋白斑塊病變的替代指標。該檢測適用於50歲及以上、在專科診療機構出現認知功能減退症狀和...

宾夕法尼亚州马尔文和东京--(BUSINESS WIRE)--(美国商业资讯)-- Fujirebio今日宣布，该公司的Lumipulse ® G pTau 217/β-淀粉样蛋白1-42血浆比值体外诊断(IVD)检测已获美国食品药品管理局(FDA)授予的510(k)上市许可。该检测用于评估阿尔茨海默病及其他认知功能减退病因患者的淀粉样蛋白病变，曾获FDA突破性器械认定，是美国首个获FDA批准用于辅助识别阿尔茨海默病(AD)相关淀粉样蛋白病变患者的血液IVD检测方法。 据估计，目前约有720万美国人受阿尔茨海默病影响，预计到2060年这一数字将增至近1400万。1该疾病是导致残疾和死亡的主要原因之一。阿尔茨海默病在症状显现前已发展多年，但由于缺乏便捷、微创的诊断手段，许多患者直到病情晚期才被确诊，此时有效干预措施已极为有限。 Lumipulse G pTau 217/β淀粉样蛋白1-42血浆比值检测通过精准、微创、便捷的方式测量血浆中pTau 217和β-淀粉样蛋白1-42的浓度，以此作为大脑β-淀粉样蛋白斑块病变的替代指标。该检测适用于50岁及以上、在专科诊疗机构出现认知功能减退症状...

NOWY JORK--(BUSINESS WIRE)--Firma DDC Enterprise Ltd. (NYSEAM: DDC) opublikowała dzisiaj wyniki finansowe za rok 2024 wraz z listem do akcjonariuszy od założycielki, prezeski i dyrektor generalnej Normy Chu, w którym podkreśla ona pozytywne wyniki finansowe firmy i przedstawia pionierską strategię akumulacji bitcoinów z myślą o zredefiniowaniu długoterminowego tworzenia wartości. Szanowni Akcjonariusze! Rok 2024 był dla DDC okresem transformacyjnego wzrostu i osiągnięcia strategicznych kamieni...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Be Biopharma, Inc. (“Be Bio”), a clinical-stage company pioneering the discovery and development of engineered B Cell Medicines (BCMs), today presented results from new preclinical research demonstrating a single administration of BE-102, a BCM for the potential treatment for Hypophosphatasia (HPP), produces continuous levels of active ALP long-term in vivo. The findings will be presented during an oral presentation at the American Society of Gene & Cell T...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today presented the most contemporary analysis of the HELIOS-B Phase 3 study of vutrisiran for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM) as a late-breaking abstract at the Heart Failure 2025 Congress, a scientific congress of the European Society of Cardiology, taking place May 17-20 in Belgrade, Serbia. The results demonstrate that vutrisiran, which rapi...

MAHIA, New Zealand--(BUSINESS WIRE)--Rocket Lab USA, Inc. (Nasdaq: RKLB) (“Rocket Lab” or “the Company”), a global leader in launch services and space systems, today successfully launched its third mission for Japanese customer, Institute for Q-shu Pioneers of Space, Inc. (iQPS). ‘The Sea God Sees’ mission successfully launched on Electron from Rocket Lab Launch Complex 1 in Mahia, New Zealand at 8:17 p.m. NZT on May 17th, 2025. The mission carried iQPS’ QPS-SAR-10, a synthetic aperture radar (...