Axsome Therapeutics登记solriamfetol治疗儿童青少年ADHD的III期开放标签长期安全性研究（NCT07773883）
Axsome Therapeutics在ClinicalTrials.gov更新登记NCT07773883：一项III期、多中心、开放标签研究，评估solriamfetol在患ADHD（注意缺陷多动障碍）的儿童青少年中的长期安全性。本次材料仅提供方案描述，未报告招募状态、样本量、主要终点或安全性结果，具体状态以登记库后续提交为准。
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ClinicalTrials.gov API v2 · 登记更新 ClinicalTrials.gov API v2 · 登记更新 BrainGate2：失语人群皮质内神经接口系统可行性研究（BG-Aphasia-01，NCT07791459）在 ClinicalTrials.gov 登记
责任方 Leigh R. Hochberg, MD, PhD 在 ClinicalTrials.gov 登记 BrainGate2 皮质内神经接口系统用于失语人群的可行性研究（BG-Aphasia-01，NCT07791459）。研究目的为获得初步器械安全性信息，并以尝试说话的方式验证失语者在计算机屏幕上生成文字及可听见的计算机生成语音的原理可行性。本次为登记摘要，未提供招募状态、分期或结果数据。
ClinicalTrials.gov API v2 · 登记更新 奥斯陆大学医院登记复发或第二原发头颈癌质子再放疗多中心II期单臂试验（NCT07922967）
奥斯陆大学医院作为责任方在ClinicalTrials.gov登记一项多中心II期单臂试验（NCT07922967），评估质子再放疗用于复发或第二原发头颈癌患者，登记更新时间为2026-11-06。
ClinicalTrials.gov API v2 · 登记更新 美国国家老龄研究所登记试验方案：psilocybin强化认知训练对老年轻度认知障碍及早期阿尔茨海默病者脑健康的影响（NCT07721467）
美国国家老龄研究所（NIA）登记NCT07721467试验方案，拟纳入65岁及以上轻度认知障碍或早期阿尔茨海默病者，亦需认知正常健康老年人，比较认知训练联合psilocybin（裸盖菇素）与单纯认知训练对脑健康的影响。方案写明psilocybin间隔2周口服1粒（第二剂可选）且给药后留院24小时，两组均每日平板脑训练并重复影像与睡眠脑波监测。本记录为方案设计，尚无结果数据。
ClinicalTrials.gov API v2 · 登记更新 六价OX40激动剂INBRX-106单药或联合帕博利珠单抗治疗局部晚期或转移性实体瘤的1/2期、开放标签、非随机4部分试验（ClinicalTrials.gov登记）
一项1/2期、开放标签、非随机、4部分试验在局部晚期或转移性实体瘤受试者中评估六价OX40激动剂INBRX-106，单独给药或与抗PD-1检查点抑制剂帕博利珠单抗（Keytruda®）联合。试验目的为确定安全性特征并确定最大耐受剂量（MTD）和/或推荐2期剂量（RP2D）。
ClinicalTrials.gov API v2 · 登记更新 安特卫普大学登记MYSSELF研究（NCT07902375）：自采样甲基化分析寻找妇科肿瘤（表观）遗传标志物
安特卫普大学在ClinicalTrials.gov登记MYSSELF研究（NCT07902375），拟分析首次尿液与阴道自采样中的（表观）遗传甲基化标志物，寻找其与子宫内膜、卵巢、外阴或阴道（癌前）病变及绝经后出血的关联。研究将以临床采集的宫颈或外阴样本以及血液、组织样本作对照，探索这些标志物未来能否帮助更早、侵入性更小的妇科肿瘤检测。该记录仅提供研究目的，材料中未给出样本量与当前招募状态等细节。
EMA · What's New精选 EMA 授权 rilzabrutinib（Wayrilz）用于既往治疗无效的成人免疫性血小板减少症
EMA 于 2025 年 12 月 22 日授予 Sanofi 的 rilzabrutinib（Wayrilz）欧盟上市授权，用于既往治疗无效的成人免疫性血小板减少症（ITP），并发布 Revision 1 的 EPAR。
关注理由：EMA 发布 rilzabrutinib（Wayrilz）欧盟上市授权 EPAR，含 202 名成人 ITP 随机对照试验数据及 12 周无效停药规则，可用于孤儿药治疗路径跟踪。
EMA · What's New 欧盟撤回阿片依赖替代治疗药Suboxone（buprenorphine/naloxone）上市许可，企业以商业原因申请永久停售
2026年9月11日，欧洲委员会应上市许可持有人Indivior Europe Limited申请撤回Suboxone（buprenorphine/naloxone）在欧盟的上市许可，原因为企业出于商业考虑永久停售。
EMA · What's New EMA 更新 Vabysmo（faricimab）欧洲公众评估报告：第11版，维持用于湿性AMD、糖尿病性黄斑水肿及RVO相关黄斑水肿
EMA 发布 Vabysmo（faricimab）第11版 EPAR，该药于2022年9月15日获批，用于治疗湿性年龄相关性黄斑变性（AMD）、糖尿病性黄斑水肿及视网膜静脉阻塞（RVO）引起的黄斑水肿。
EMA · What's New精选 EMA将多发性骨髓瘤药teclistamab（Tecvayli）的条件性上市许可转为标准许可（EPAR第11版）
EMA更新teclistamab（Tecvayli）的EPAR：该药用于复发或难治性多发性骨髓瘤成人患者，2022年8月23日获欧盟条件性上市许可，2026年8月20日因公司提交额外数据转为标准上市许可。
关注理由：该EPAR第11版记录teclistamab由条件性上市许可转为标准许可这一监管证据升级，并汇总其单药及联合daratumumab研究的疗效与安全性数据，便于跟踪多发性骨髓瘤后续监管动作。
EMA · What's New EMA发布Galafold（migalastat）EPAR第19版摘要：法布雷病治疗药，2016年5月25日获批，状态Authorised
EMA发布Galafold（活性成分migalastat）欧洲公众评估报告（EPAR）摘要，该药2016年5月25日获欧盟上市许可，现行第19版，状态为Authorised，用于12岁及以上、携带特定α-半乳糖苷酶A基因突变的法布雷病患者。
EMA · What's New精选 EMA通报止吐药Emend（aprepitant）欧盟/EEA供应短缺，Merck Sharp & Dohme B.V.因商业原因计划2028年5月前永久停市
EMA通报Merck Sharp & Dohme B.V.因商业原因永久停市止吐药Emend（aprepitant，80 mg与125 mg规格），欧盟/EEA短缺持续，预计2028年5月前在所有国家停市，停市与产品质量缺陷或安全问题无关。
关注理由：该通告确认aprepitant停市源于商业原因而非质量或安全问题，6月龄及以上儿童所需口服混悬剂型无替代品，是化疗支持用药供应需持续跟踪的关键缺口。
EMA · What's New EMA兽医药品委员会对Scovella（velagliflozin）出具积极意见，推荐授予用于非食用马代谢综合征的上市许可
2026年11月5日，EMA兽医药品委员会（CVMP）通过积极意见，推荐授予Boehringer Ingelheim Vetmedica GmbH申请的Scovella（15 mg/ml口服溶液。
EMA · What's New EMA兽医药品委员会对Aniserve GmbH犬淋巴瘤兽药Laverdia（verdinexor）作出积极意见，推荐授予上市许可（EMA/CVMP/245870/2026）
2026年11月5日，EMA兽医药品委员会（CVMP）对Aniserve GmbH申请的犬淋巴瘤药Laverdia（活性成分verdinexor）作出积极意见，推荐授予上市许可，用于增加II、III、IV期淋巴瘤犬的进展时间（家庭环境用药）。
EMA · What's New EMA CVMP对Intervet International B.V.犬用疫苗Nobivac PLUS DHPPi/Leptos（针对犬瘟热、腺病毒、副流感、细小病毒及钩端螺旋体）采纳积极意见，建议授予上市许可，欧盟委员会决定待定
2026年11月5日，EMA兽医药品委员会（CVMP）对Intervet International B.V.的犬用疫苗Nobivac PLUS DHPPi/Leptos采纳积极意见，建议授予上市许可。
EMA · What's New 欧洲药品管理局CVMP对犬用四联抗寄生虫咀嚼片Credelio Quattro采纳正面意见，推荐授予上市许可
欧洲药品管理局兽药委员会（CVMP）于2026年11月5日对Elanco GmbH申请的犬用咀嚼片Credelio Quattro（lotilaner/moxidectin/pyrantel/praziquantel）采纳正面意见，认为效益-风险平衡有利，推荐授予上市许可。
EMA · What's New EMA兽药产品委员会（CVMP）对Elanco GmbH兽药Credelio（lotilaner）猫耳螨适应症上市许可变更采纳正面意见
2026年11月5日，EMA兽药产品委员会（CVMP）对Elanco GmbH兽药Credelio（lotilaner）上市许可变更采纳正面意见，该变更涉及猫适应症的新增或修改：治疗耳螨（Otodectes cynotis）感染。该意见尚待欧盟委员会批准，更新后的产品特性概要（SPC）将载于欧盟产品数据库（UPD）。
EMA · What's New EMA 短缺通报：Emend（aprepitant，80 mg 硬胶囊、125 mg 硬胶囊、125 mg 口服混悬用粉末）计划永久停止上市
EMA 发布药品短缺通报（Medicine shortage communication），称 Emend（aprepitant）80 mg 硬胶囊、125 mg 硬胶囊和 125 mg 口服混悬用粉末三种制剂计划永久停止上市。该文件为计划性停售通知，性质属供应中断信号而非安全召回或疗效问题。材料仅含通报标题信息，未说明停售原因、生效时间表或替代供应安排。
EMA · What's New EMA发布Entresto（sacubitril/valsartan，沙库巴曲/缬沙坦）欧洲公共评估报告（EPAR）第28版：维持欧盟已授权状态（2015年11月19日批准），用于成人及1岁及以上患儿的慢性心力衰竭
EMA发布Entresto（沙库巴曲/缬沙坦）EPAR第28版：该药在欧盟已授权，用于成人及1岁以上儿童慢性心力衰竭。成人主研究中，Entresto组心血管死亡或心衰住院21.8%对依那普利26.5%，因优效提前停止。1个月至<18岁377例患儿主要结局未显示优于依那普利；常见不良事件为高钾血症、低血压、肾功能损害。
WHO · Disease Outbreak News OData 诊断与检测：Ebola disease caused by Bundibugyo virus - Democratic Republic of the Congo, Kenya and Nigeria
原文摘录：See all DONs related to this event Read more about Ebola disease Situation at a glance Since the publication of the previous Disease Outbreak News on 23 October 2026, the Bundibugyo virus disease (BVD) outbreak has expanded geographically in the Democrati … item/2026-DON625
WHO · Disease Outbreak News OData 感染病学：Yellow fever - WHO African Region
原文摘录：See all DONs related to this event Read more about Yellow fever Situation at a glance Yellow fever transmission continues in the WHO African Region, with recent outbreak activity concentrated in parts of West Africa. … item/2026-DON624
EMA · What's New 心血管医学：Human medicines European public assessment report (EPAR): Rivaroxaban Viatris (previously Rivaroxaban Mylan), rivaroxaban, Date of authorisation: 12/11/2021, Revision: 12, Status: Authorised
原文摘录：Rivaroxaban Viatris (previously Rivaroxaban Mylan) RSS Authorised This medicine is authorised for use in the European Union rivaroxaban Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview Rivaroxaban M … 21 MB - DOCX) First published: 04/06/2025 View This page was last updated on 06/11/2026
EMA · What's New 儿科学：Human medicines European public assessment report (EPAR): Yorvipath, palopegteriparatide, Date of authorisation: 17/11/2023, Revision: 6, Status: Authorised
原文摘录：Yorvipath RSS Authorised This medicine is authorised for use in the European Union palopegteriparatide Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview Yorvipath is a hormone replacement medicine fo … 37 KB - PDF) First published: 15/09/2023 View News on Yorvipath Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023 15/09/2023 More information on Yorvipath EU/3/20/2350 - orphan designation for treatment of hypoparathyroidism EMA/PE/0000241327 - paediatric investigation plan A Study to Assess the Amount of Palopegteriparatide in Breast Milk of Lactating Females Requiring YORVIPATH® (Palopegteriparatide) - post-authorisation study A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding - post-authorisation study This page was last updated on 06/11/2026
EMA · What's New 神经内科：Human medicines European public assessment report (EPAR): Aldurazyme, laronidase, Date of authorisation: 09/06/2003, Revision: 28, Status: Authorised
原文摘录：Aldurazyme RSS Authorised This medicine is authorised for use in the European Union laronidase Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview This is a summary of the European public assessment re … This page was last updated on 06/11/2026
EMA · What's New 儿科学：Human medicines European public assessment report (EPAR): Bylvay, odevixibat, Date of authorisation: 16/07/2021, Revision: 13, Status: Authorised
原文摘录：Bylvay RSS Authorised This medicine is authorised for use in the European Union odevixibat Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview Bylvay is a medicine for treating patients from the age of … More information on Bylvay EU/3/12/1028 - orphan designation for treatment of progressive familial intrahepatic cholestasis EU/3/12/1040 - orphan designation for treatment of Alagille syndrome EMEA-002054-PIP01-16-M03 - paediatric investigation plan EMA/PE/0000240317 - paediatric investigation plan Bylvay - withdrawal of application for variation to marketing authorisation Registry to Document Treatment Effectiveness, Safety, Including Prospective Long-term Outcomes in Participants with Progressive Familial Intrahepatic Cholestasis (PFIC) who take Odevixibat (Bylvay) - post-authorisation study Prospective Registry-Based Study Evaluating the Effectiveness and Safety of Odevixibat in Participants With Alagille Syndrome (ALGS) - post-authorisation study Prospective Registry-Based Study of the Long-Term Safety of Odevixibat in Patients with Progressive Familial Intrahepatic Cholestasis (PFIC) - post-authorisation study This page was last updated on 06/11/2026
EMA · What's New 感染病学：Human medicines European public assessment report (EPAR): Comirnaty, COVID-19 mRNA vaccine, Date of authorisation: 21/12/2020, Revision: 64, Status: Authorised
原文摘录：Comirnaty RSS Authorised This medicine is authorised for use in the European Union COVID-19 mRNA vaccine Medicine Human Authorised Rolling review Application under evaluation CHMP opinion European Commission decision Overview Comirnaty is a vaccine for pr … 5-containing Covid-19 mRNA vaccines in the Nordic countries - post-authorisation study A Non-Interventional Post-Authorization Safety Study (PASS) for Active Safety Surveillance of Recipients of the Pfizer-BioNTech COVID-19 mRNA vaccine in the EU - post-authorisation study Real-world effectiveness of different COVID-19 vaccines in Spain: a cohort study based on public electronic health records (BIFAP) (effectiveness of COVID-19 vaccines in Spain) - post-authorisation study This page was last updated on 06/11/2026
EMA · What's New 感染病学：Human medicines European public assessment report (EPAR): Entyvio, vedolizumab, Date of authorisation: 22/05/2014, Revision: 34, Status: Authorised
原文摘录：Entyvio RSS Authorised This medicine is authorised for use in the European Union vedolizumab Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview Entyvio is a medicine used to treat adult patients with … 73 KB - PDF) First published: 21/03/2014 Last updated: 21/03/2014 View News on Entyvio Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 2021 17/12/2021 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 February 2020 28/02/2020 European Medicines Agency recommends 39 medicines for human use for marketing authorisation in first half of 2014 10/07/2014 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 March 2014 21/03/2014 European Medicines Agency recommends approval of a locally targeted treatment for ulcerative colitis and Crohn's disease 21/03/2014 More information on Entyvio EMEA-000645-PIP03-18 - paediatric investigation plan EMEA-000645-PIP01-09-M09 - paediatric investigation plan EMEA-000645-PIP04-20-M02 - paediatric investigation plan Vedolizumab-4081: Infection Outcomes among Advanced Therapy-naive Older Adult US Patients With UC/CD Initiating ENTYVIO, TNF-alpha Inhibitors, or Ustekinumab: A Retrospective Observational Matched-Cohort Study Using Medicare Claims Data, 2016-2025 - post-authorisation study Vedolizumab-5001: Organization of Teratology Information Specialists (OTIS) Vedolizumab Pregnancy Exposure Registry - post-authorisation study Vedolizumab-5056: Clinical Effectiveness of Vedolizumab Used in Frames of Drug Program for Crohn’s Disease Treatment in Poland – Prospective, Observational Study Considering Fatigue and Other Patient-reported-outcomes (PROs) (POLONEZ II) - post-authorisation study Comparative Effectiveness of Tofacitinib Versus Ustekinumab and Vedolizumab among Ulcerative Colitis Patients With Prior Anti- Tumor Necrosis Factor (TNF) Failure - post-authorisation study Topics Medicines This page was last updated on 06/11/2026
EMA · What's New 神经内科：Human medicines European public assessment report (EPAR): Lacosamide Accord, lacosamide, Date of authorisation: 18/09/2017, Revision: 14, Status: Authorised
原文摘录：Lacosamide Accord RSS Authorised This medicine is authorised for use in the European Union lacosamide Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview This is a summary of the European public assess … 56 KB - DOCX) First published: 28/05/2025 View This page was last updated on 06/11/2026
EMA · What's New 急诊与重症医学：Human medicines European public assessment report (EPAR): Elaprase, idursulfase, Date of authorisation: 08/01/2007, Revision: 29, Status: Authorised
原文摘录：Elaprase RSS Authorised This medicine is authorised for use in the European Union idursulfase Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview This is a summary of the European public assessment rep … This page was last updated on 06/11/2026
EMA · News and Safety Reviews 肿瘤学：Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 3-5 November 2026
原文摘录：Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 3-5 November 2026 6 November 2026 Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting News Veterinary Medicines CVMP opinions on veterinary medicinal pro … Related content Committee for Medicinal Products for Veterinary Use (CVMP): 3-5 November 2026 Committee for Veterinary Medicinal Products (CVMP) Related medicine information Credelio Quattro Credelio Nobivac PLUS DHPPi / Leptos Laverdia Scovella
ClinicalTrials.gov API v2 · 登记更新 内分泌与代谢：Slowly Digestible Carbohydrates for GLP-1 Secretion
原文摘录：The goal of this clinical trail is to learn if the hormone, glucagon-like peptide-1 (GLP-1), is stimulated by slowly digestible carbohydrates (SDCs) in healthy adults.
ClinicalTrials.gov API v2 · 登记更新 ClinicalTrials.gov登记更新：Tafasitamab联合Acalabrutinib与Venetoclax治疗慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL）的II期试验
ClinicalTrials.gov登记更新一项II期试验，评估tafasitamab联合acalabrutinib与venetoclax治疗慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL）的安全性、副作用与疗效。三药分别为靶向CD19的单克隆抗体、阻断BTK的激酶抑制剂和BCL-2抑制剂。试验假设该三药联合方案对CLL/SLL患者可能安全有效。
ClinicalTrials.gov API v2 · 登记更新 行业资料：Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
原文摘录：The purpose of this 1-year open-label extension study is to characterize the longer-term safety and tolerability of DDY391 and to assess the durability of clinical response in participants with Psoriatic Arthritis (PsA) who have completed treatment in the
ClinicalTrials.gov API v2 · 登记更新精选 肿瘤学：Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
原文摘录：This phase I/II trial studies the side effects and the best dose of selumetinib and how well it works in treating or re-treating young patients with low grade glioma that has come back (recurrent) or does not respond to treatment (refractory).
关注理由：这条肿瘤学内容涉及相关临床或研究问题，建议查看原文中的方法与适用范围。
WHO · Official News OData 行业资料：Civil society discusses its role in strengthening trust in science
原文摘录：Non-State actors information and engagement session 7 October 2026 Amid growing mistrust in science and widespread health misinformation, the WHO Civil Society Commission and the WHO Chief Scientist’s Office held an information session for non-State actor … int
WHO · Official News OData 行业资料：FoodMed 2026 highlights the role of food, traditional knowledge and science in advancing health
原文摘录：Dr Geetha Krishnan Gopalakrishna Pillai of WHO Global Centre for Traditional Medicine, delivering his keynote at FoodMed 2026 Conference The FoodMed Conference returned for its second edition on 5–6 November 2026, bringing together international experts,
ClinicalTrials.gov API v2 · 登记更新 神经内科：Case-Specific Health Care Professional Clinical Survey of Liberant™ Thrombectomy System
原文摘录：The purpose of Case-Specific Health Care Professional (HCP) Clinical Survey of Liberant™ Thrombectomy System, also known as the Liberant Clinical Assessment, is to collect first-in-human clinical data to confirm the safety and performance of the Medtronic
WHO · Official News OData 儿科学：WHO at COP31: Health Day opens two weeks of activities to deliver on climate change and health
原文摘录：On Monday, 9 November, health takes centre stage as the thirty-first session of the Conference of the Parties (COP31) to the UN Framework Convention on Climate Change (UNFCCC) opens with a dedicated Health Day. … ATACH and AIR give countries the means to do that, during COP31 and beyond
ClinicalTrials.gov API v2 · 登记更新 肿瘤学：A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
原文摘录：This is a prospective, single-arm study in patients with locally advanced or metastatic pancreatic cancer that cannot be treated with surgery. The study is planned to enroll 42 patients.
ClinicalTrials.gov API v2 · 登记更新 肿瘤学：Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
原文摘录：Background: Cancers that begin in the colon, adrenal glands, or bile ducts may spread to the liver. These liver tumors are often treated using a hepatic artery infusion (HAI) pump.