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CINCINNATI--(BUSINESS WIRE)--Eyas Medical Imaging, Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Ascent3T™ Neonatal Magnetic Resonance Imaging (MRI) System, a whole-body magnetic resonance scanner designed and optimized specifically for neonate and infant anatomy, including head, body, and extremities. “510(k) clearance marks a significant milestone for the company and reflects our mission to enable healthcare professionals to save more babies’ lives with st...

威斯康辛州麥迪森--(BUSINESS WIRE)--(美國商業資訊)-- 中國國家藥品監督管理局(NMPA)已核准OncoMate® 微衛星不穩定性(MSI)檢測試劑盒為中國三類體外診斷醫療器材。該試劑盒擬做為伴隨診斷試劑，用於辨識高微衛星不穩定性(MSI-H)實質腫瘤病患，以接受美國紐澤西州拉威市Merck & Co., Inc.的抗PD-1療法——KEYTRUDA® (pembrolizumab)治療。這是Promega首款獲得NMPA核准的伴隨診斷試劑。 Promega全球臨床市場總監Alok Sharma表示：「此次核准代表中國在實現更具個人化、更有效的癌症治療方面邁出了重要一步。我們很驕傲能與製藥企業合作，提供全球解決方案，擴大創新技術和挽救生命的有效療法的可及性。」 中國仍是全球癌症負擔最重的國家之一，實質腫瘤占全國癌症確診病例的絕大多數。儘管腫瘤治療領域取得了諸多進展，但大多數晚期實質腫瘤病患在一線治療後最終仍會出現疾病惡化，因此迫切需要能指導更有效的替代治療策略的工具。OncoMate® MSI檢測試劑盒是一種以聚合酶鏈反應(PCR)技術為基礎的檢測方法，旨在...

威斯康星州麦迪逊--(BUSINESS WIRE)--(美国商业资讯)-- 中国国家药品监督管理局(NMPA)已批准OncoMate® 微卫星不稳定性(MSI)检测试剂盒作为中国三类体外诊断医疗器械。该试剂盒拟作为伴随诊断试剂，用于识别高微卫星不稳定性(MSI-H)实体瘤患者，以接受美国新泽西州拉威市Merck & Co., Inc.的抗PD-1疗法——KEYTRUDA® (pembrolizumab)治疗。这是Promega首款获得NMPA批准的伴随诊断试剂。 Promega全球临床市场总监Alok Sharma表示：“此次批准标志着中国在实现更具个性化、更有效的癌症治疗方面迈出了重要一步。我们很自豪能与制药企业合作，提供全球解决方案，扩大创新技术和挽救生命的有效疗法的可及性。” 中国仍是全球癌症负担最重的国家之一，实体瘤占全国癌症确诊病例的绝大多数。尽管肿瘤治疗领域取得了诸多进展，但大多数晚期实体瘤患者在一线治疗后最终仍会出现疾病进展，因此迫切需要能指导更有效的替代治疗策略的工具。OncoMate® MSI检测试剂盒是一种基于聚合酶链反应(PCR)技术的检测方法，旨在评估肿...

MADISON, Wis.--(BUSINESS WIRE)--De NMPA (National Medical Products Administration) heeft de OncoMate® Microsatellite Instability (MSI) Detection Kit goedgekeurd als een in vitro diagnostisch medisch hulpmiddel van klasse III in China. Het is bedoeld voor gebruik als een begeleidende diagnostiek om patiënten met vaste MSI-H (MSI-High) tumoren te identificeren voor behandeling met KEYTRUDA® (pembrolizumab), de anti-PD-1-therapie van Merck & Co., Inc., Rahway, NJ, USA. Dit is de eerste begelei...

PARK CITY, Utah & IRVINE, Calif.--(BUSINESS WIRE)--BioSelective Capital Investments and Shayan Enterprises, LLC, a Utah-based risk-capital investment firm, today announced the successful acquisition of BioDuro’s drug product development and manufacturing operations in Irvine, California, resulting in the formation of Forma Life Sciences, Inc. (FORMA), a Delaware corporation established to hold and operate the acquired assets. The transaction includes two highly accredited facilities supporting...

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Hologic Receives FDA Approval for Aptima® HPV Assay Primary Screening Option, Expanding Cervical Health Portfolio...

SAN MATEO, Calif.--(BUSINESS WIRE)--RapidAI, the pioneer of deep clinical AI and global leader in enterprise imaging, today announced details of 28 scientific abstracts accepted at the International Stroke Conference (ISC) 2026, held February 4-6, at the Ernest N. Morial Convention Center in New Orleans. The abstracts span aneurysm monitoring, ischemic stroke detection, advanced imaging visualization, and radiology workflow optimization. Findings reflect the impact of deep clinical AI delivered...

SUNNYVALE, Calif.--(BUSINESS WIRE)--Integrated DNA Technologies on Passage of Medicare Multi-Cancer Early Detection Screening Coverage Act...

WALTHAM, Mass.--(BUSINESS WIRE)--Affinia Therapeutics (“Affinia”), an innovative gene therapy company with a pipeline of first-in-class and/or best-in-class adeno-associated virus (AAV) gene therapies initially for devastating cardiovascular diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for AFTX-201, an investigational genetic medicine for the treatment of BAG3 DCM. “We are grateful to the FDA for the timel...

BOSTON--(BUSINESS WIRE)--Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced preliminary, unaudited fourth quarter and full year 2025 net product revenues for AVMAPKI™ FAKZYNJA™ CO-PACK, business updates, and 2026 priorities. "2025 was a transformative year for Verastem Oncology and the patients we serve. We transitioned to a commercial-stage company with the launch of AVMAPKI FAKZY...