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。
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EMA · What's New 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。
STAT · 医学与生命科学新闻 诺和诺德ziltivekimab在ZEUS试验中未减少心血管事件，心脏病学家表示仍将探索抗炎治疗
诺和诺德单克隆抗体ziltivekimab在ZEUS试验中降低了炎症细胞因子IL-6水平，但在病情严重的患者中，相比安慰剂未减少心肌梗死、卒中或死亡；结果在美国心脏协会科学年会公布并同步发表于《新英格兰医学杂志》。因数据监查委员会9月判定不太可能成功，诺和诺德已停止该药另外两项试验HERMES与ATHENA。报道引述心脏病学家观点：尽管该药失败，仍将继续探索抗炎治疗。
KFF Health News · 健康政策与医学新闻 解读：美国得州民主党赢得州级选举，医保扩面与控费议程落地面临阻力
KFF Health News分析称，得州民主党11月3日赢得州长、副州长等州级职位和州众议院，选民对医疗费用与就医困难的不满被视为原因之一。该州近3200万居民中约500万人无医保、含100万儿童；若扩面Medicaid约100万人将新获资格，联邦承担90%费用，但共和党仍控制州参议院。140天立法会期1月12日开始，下次常规会期到2029年，扩大覆盖、降低费用与改善女性健康的落地路径仍未明确。
The Lancet · Online 肾脏病学：[Comment] Preparing for dialysis when dialysis might never begin?
原文摘录：For older people (aged ≥80 years) with frailty or multimorbidity living with kidney failure, choosing a care pathway could involve deciding whether to prepare for dialysis long before it is needed.
The Lancet · Online 神经内科：[Clinical Rounds] Vertigo, multifocal brain lesions, and a diagnostic clue on the skin
原文摘录：A woman aged 35 years was evaluated for a 1-year history of recurrent, brief (approximately 15 min) episodes of non-positional vertigo described as a spinning sensation. … Neurological and vestibular examinations, including audiometry and the Dix–Hallpike manoeuvre, were normal between episodes
STAT · 医学与生命科学新闻 俄勒冈等四州再次起诉特朗普政府，寻求推迟Medicaid工作要求实施
俄勒冈、明尼苏达、新墨西哥和华盛顿四州向俄勒冈联邦地区法院起诉特朗普政府，指控Medicaid全面改革将造成“不可挽回的主权、财政和公共卫生损害”，并称政府无权强制各州实施。此前不到一周，联邦法官曾裁定工作要求实施将造成“不可挽回的损害”；诉讼距2025年通过法案规定的1月1日期限不足60天，该条款要求受益人每月工作、志愿服务或上学80小时以保留医疗保险，残障等少数情况例外。
STAT · 医学与生命科学新闻 STAT+：MAHA领导人Calley Means抨击白宫官员屈从产业界
上月离职白宫及联邦卫生机构的MAHA领导人Calley Means在Joe Rogan播客录音中称，白宫高层官员因产业界影响和资金调整政策。他举例称，部分MAHA倡导者主张草甘膦有严重健康危害，产业团体曾施压机构反对研究或限制该除草剂，一名白宫官员随后向他提交促进草甘膦生产的政策并称不容讨论。全文为STAT+付费报道。
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
STAT · 医学与生命科学新闻 民主党赢得国会参众两院控制权，拟逆转Medicaid削减并永久恢复ACA增强补贴，医院行业支付压力有望缓解
据STAT报道，民主党在中期选举中赢得参众两院控制权，医院行业面临的Medicaid进一步削减压力有望缓解。该党领导人备忘录显示，民主党拟在新一届国会开局的前100小时内推动逆转特朗普税法中的Medicaid削减、“永久恢复”今年早些时候到期的《平价医疗法案》（Affordable Care Act）增强补贴，并阻止特朗普政府提出的一项被医院界反对的小众药品折扣模式。
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
KFF Health News · 健康政策与医学新闻 2026中期选举后“Medicare for All”（全民医保）议题走向分析（KFF Health News报道）
KFF Health News报道称，2026年美国中期选举后，多位在密歇根、得克萨斯、艾奥瓦、缅因等州以“Medicare for All”（全民医保）为标志议题竞选的民主党人当选，支持者视其为推进单一支付体系的机会。
PubMed · BMC Public Health 瑞典63,000名青少年潜在画像研究：市政学校卫生服务支出与双因子心理健康画像不均等关联
瑞典斯德哥尔摩地区2006–2024年63,190名九年级学生的潜在画像研究显示，完全心理健康比例从55.6%降至45.4%，Troubled画像从3.4%升至7.2%。
PubMed · Neurology 神经内科：Overlooked Writings of Sir William Gowers on Neurology in General Practice, Shorthand, and Education.
原文摘录：Sir William Richard Gowers (1845-1915), long hailed as the "Father of Clinical Neurology," has been the subject of 2 biographies and many essays relating to his contributions to the study of nervous disorders. … Recovered only through primary source research, these writings broaden our understanding of Gowers' intellectual range, showing him not only as a pioneering specialist in the study of nervous disorders but also as a physician engaged with general medicine and educational reform
PubMed · Journal of Nutrition 老年医学：A vegetarian meal reduces protein digestibility without altering postprandial protein utilization in old rats.
原文摘录：BACKGROUND: The composition of the meal, particularly its plants-based components, may reduce protein digestibility and amino acid (AA) availability. … Long-term studies should det
PubMed · PLoS ONE 诊断与检测：Epidemiological surveillance of bacterial pathogens in cultured European sea bass (Dicentrarchus labrax) along the Aegean coast of Türkiye.
原文摘录：Intensive aquaculture of European sea bass (Dicentrarchus labrax) along the Aegean coast of Türkiye faces continuous production challenges from infectious diseases, yet comprehensive multi-year baseline data remain limited.
PubMed · Journal of Medical Internet Research 临床护士对生成式AI的态度与经验：定性系统综述
发表于 Journal of Medical Internet Research 的定性系统综述（PMID 42993795）整合2018年1月至2026年6月间注册护士使用生成式AI（GenAI）临床实践的定性证据，检索10个中英文数据库，采用Thomas和Harden三阶段主题合成并结合TAM-AIN框架，以GRADE-CERQual评估证据确定性。
PubMed · American Journal of Physiology-Cell Physiology 膜片钳直接记录证实伤寒沙门菌含菌空泡膜上存在TRPML2依赖的阳离子电导（体外研究）
研究以伤寒沙门菌感染THP-1细胞为模型，首次对含病原体空泡（SCV）膜直接进行膜片钳记录。野生型细胞SCV在负电位下呈现强内向电流，在TRPML2敲除细胞中减弱并可被TRPML2激动剂增强，且显示TRPML2依赖的Mg²⁺和Ca²⁺电导；PI3P可减缓电流衰减。该体外电生理研究为宿主-病原体界面离子通道功能研究建立了平台，未涉及患者结局。
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.
PubMed · PLoS Computational Biology kinGEMs：结合深度学习预测动力学参数随机调优的计算框架，为93个物种构建酶约束基因组规模代谢模型
PLoS Computational Biology 2026-11-06 在线发表一项计算研究，提出整合 CPI-Pred 深度学习模型与 kinGEMs 流程的框架，从序列和化合物嵌入预测催化常数 kcat，并将不确定性参数纳入酶约束基因组规模模型。
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