EMA 更新 Cosentyx(secukinumab)EPAR 至第 44 版,欧盟上市许可状态为已批准
EMA 更新 secukinumab(Cosentyx)欧洲公众评估报告至第 44 版,该药 2015 年 1 月 14 日获欧盟上市许可,持证方 Novartis Europharm,状态为已批准。
EMA 更新 secukinumab(Cosentyx)欧洲公众评估报告至第 44 版,该药 2015 年 1 月 14 日获欧盟上市许可,持证方 Novartis Europharm,状态为已批准。
EMA更新Ogsiveo(活性物质nirogacestat)的EPAR至第5版,该药于2025年8月14日获欧盟上市授权,用于需要全身治疗、肿瘤进展的成人硬纤维瘤患者单药治疗,此前为孤儿药。
EMA将Jyseleca(活性成分filgotinib)的EPAR更新至Revision 15,该药2020年9月24日在欧盟获批,现状态为Authorised;最新变更VR/0000325892的CHMP积极意见已采纳,评估报告与产品信息于2026年11月5日更新。
EMA于2026年11月5日在“审评员模板”程序性指导页面新增PSUSA评估报告模板板块,含CAPs与NAPs两个模板,均为当日首次发布。页面另汇集PAM、信号评估、风险管理计划(RMP)、PRAC建议、II类变更及市场/数据保护延长等评估报告模板。此次为程序性指导文件增补,不涉及药物批准或疗效结论。
中国疾控中心发布截至2026年11月1日的第44周流感监测周报:南方省份流感病毒检测阳性率略降、北方上升,阳性样本中甲型占65.4%、乙型占34.6%,全国共报告106起流感样病例暴发疫情。
原文摘录:One in four adolescents worldwide reported not getting at least 60 minutes of physical activity on any day in the previous week. … Stand with science”, the theme of World Health Day 2026, marks a year-long campaign to highlight science as the foundation for protecting health and well-being worldwide
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WHO候选疫苗优先技术咨询小组基于现有临床前和早期临床证据,建议将牛津大学与印度血清研究所的ChAdOx1及Moderna的mRNA-1469加入刚果(金)Tumaini试验,系针对Bundibugyo病毒的疫苗首次在疫情期间接受临床评估,待国家批准后入组。
关注理由:针对Bundibugyo病毒的候选疫苗首次在疫情期间进入临床评估,Tumaini多疫苗试验与治疗研究并行推进,结果时间表明确,可跟踪疫情期间疫苗评价模式的验证进展。
原文摘录:WHO / Monika Mey Local health workers in Cambodia are trained in surveillance techniques, including stool examination using Kato-Katz, to detect schistosomiasis eggs, identify potential hotspots and support early detection and treatment. … int Related Global report on neglected tropical diseases 2026 Ending the neglect to attain the Sustainable Development Goals: A road map for neglected tropical diseases 2021–2030 WHO's work on neglected tropical diseases More WHO Global Neglected Tropical Diseases Programme
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原文摘录:Six proven climate and health measures could save 1.6 million lives a year while delivering trillions of dollars in economic and fiscal gains, according to a new World Health Organization (WHO) report released today.
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原文摘录:Truqap - withdrawal of application for variation to marketing authorisation Application withdrawn The application for a change to this medicine's authorisation has been withdrawn capivasertib Post-authorisation Human Overview AstraZeneca AB withdrew its a … News on Truqap Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2026 16/10/2026 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024 26/04/2024 More information on Truqap Truqap This page was last updated on 03/11/2026
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FDA CDRH发布早期预警,通报潜在高风险器械问题:Compact Medical对部分批次ButterflyBVM一次性球囊面罩(BVM)复苏器发出紧急医疗器械召回通知,建议移除000109–000117批次,000081–000108批次须每次使用前完成使用前测试。
关注理由:FDA CDRH以Early Alert标记该潜在高风险器械问题,区分需移除批次与仅需使用前测试的批次,可据此跟踪急救通气器械的受影响范围与后续监管更新。
原文摘录:See all DONs related to this event Situation at a glance On 20 October 2026, the National IHR Focal Point (NFP) of France notified WHO regarding the first documented human infection with Shamonda virus (SHAV). … item/2026-DON623
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FDA 于2026年10月30日发布安全通告,多起报告称1.5–2.5岁幼儿食用 Once Upon a Farm Tractor Wheels 有机幼儿软烤棒后发生完全气道阻塞、无法呼吸,建议消费者勿购买或喂食并立即丢弃。
关注理由:FDA 报告多名1.5–2.5岁幼儿食用该软烤棒后发生常规急救难以解除的完全气道阻塞,且产品经全美主要零售渠道销售,属需持续跟踪更新的母婴食品安全预警。
原文摘录:CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that B. … Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program
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中国疾控中心(中国预防医学科学院)主任王健伟在《瞭望》2026年第44期撰文,围绕“预防为主”提出把主动预防转化为治理自觉、多病同防转化为制度安排、医防协同转化为体制突破、新质生产力转化为体系能力。
原文摘录:Image credit: © tadamichi | stock.adobe.com Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26 - 29 October 2026 30 October 2026 PRAC starts review of depression and anxiety medicine Deanxit and a safety signal related to hu … eu All other enquiries please submit your request via the online form Follow us on Bluesky Related medicine information Flupentixol/melitracen-containing medicinal products - referral Topics Pharmacovigilance
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原文摘录:This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. … Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program
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原文摘录:This recall involves implementing additional recommendations on the use of the StatStrip Glucose Hospital Meter System while awaiting a software update. … 10/20/2026 The FDA issued a communication notifying the public of a Class I Recall
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原文摘录:EMA closed on All Souls' Day, 2 November 29 October 2026 The European Medicines Agency's (EMA) office is closed from 18:00 on Friday 30 October until 08:30 on Tuesday 3 November News Corporate EMA’s office is closed on Monday 2 November, to mark All Souls
原文摘录:CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. … Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program
关注理由:这条呼吸病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。
原文摘录:Ibrance - withdrawal of application for variation to marketing authorisation Application withdrawn The application for a change to this medicine's authorisation has been withdrawn palbociclib Post-authorisation Human Overview Pfizer Europe MA EEIG withdre … News on Ibrance Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2026 16/10/2026 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2016 (corrected) 21/09/2016 New treatment for breast cancer 16/09/2016 More information on Ibrance Ibrance This page was last updated on 28/10/2026
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中国流感流行情况概要(截至2026年 10 月 25 日) ·监测数据显示,本周南方省份流感病毒检测阳性率略有下降、北方省份流感病毒检测阳性率略有上升,全国检出流感阳性样本中甲型流感病毒占比67.6%、乙型流感病毒占比32.4%;甲型流感病毒中A(H1N1)pdm09占比32.8%、A(H3N2)占比67.2%,乙型流感病毒均为B(Victoria)系。全国共报告145起流感样病例暴发疫情。
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北京脑科学与类脑研究所与北京芯智达神经技术有限公司联合实施的“北脑一号”智能脑机科技助残重建瘫痪患者运动功能应用场景,入选国家发展改革委等部门发布的首批136项国家标志性重大应用场景项目。该系统为临床阶段半侵入式、无线全植入脑机系统,已完成44余例人体植入,最长植入超过20个月,累计人体安全工作时长超17万小时,注册临床试验患者入组全部完成。项目计划2027年申报医疗器械注册证。
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 8 October 2026, the Bundibugyo virus disease (BVD) outbreak has expanded geographically in the Democratic … item/2026-DON622
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原文摘录:Image credit: © peterschreiber.media | stock.adobe.com AMA and EMA issue joint guidance on Ebola vaccine development 23 October 2026 Clinical trial requirements defined for rapid development of Bundibugyo virus vaccines News Human Clinical trials Research … eu All other enquiries Please submit your request via the online form
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中国流感流行情况概要(截至2026年 10 月 18 日) ·监测数据显示,本周南、北方省份流感病毒检测阳性率略有上升,全国检出流感阳性样本中甲型流感病毒占比66.1%、乙型流感病毒占比33.9%;甲型流感病毒中A(H1N1)pdm09占比19.4%、A(H3N2)占比80.6%,乙型流感病毒均为B(Victoria)系。全国共报告28起流感样病例暴发疫情。
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原文摘录:Summary Company Announcement Date: October 21, 2026 FDA Publish Date: October 21, 2026 Product Type: Animal & Veterinary Drugs Reason for Announcement: Recall Reason Description Potential Potency Issues Company Name: Wedgewood Pharmacy, LLC. … Company Contact Information Consumers: Sedgwick 866-562-5931
原文摘录:Driving frequently exposes individuals to conditions triggering acute stress, but its effects on drivers' visual behaviour remain insufficiently understood. … They also indicate that multimodal context-aware validation is needed for translation into real-time driver state monitoring and safety-relevant assistance applications
原文摘录:Kaftrio - withdrawal of application for variation to marketing authorisation Application withdrawn The application for a change to this medicine's authorisation has been withdrawn ivacaftor / tezacaftor / elexacaftor Post-authorisation Human Overview Vert … News on Kaftrio Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2026 18/09/2026 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 February 2025 28/02/2025 Combination of cystic fibrosis medicines to treat patients with rare mutations 28/02/2025 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023 15/09/2023 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 November 2021 12/11/2021 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 March 2021 26/03/2021 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 June 2020 26/06/2020 New medicine for cystic fibrosis patients 26/06/2020 More information on Kaftrio Kaftrio This page was last updated on 20/10/2026
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原文摘录:CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. … Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program
关注理由:这篇儿科学内容涉及具体研究方向,原文中的样本、结局和限制有助于理解其价值。
原文摘录:October 20, 2026 The U.S. Food and Drug Administration (FDA) is alerting health care providers about an import alert for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation (Olympus) and its subsidiaries. … Additional Resources Import Alert 89-04 [10/19/2026] FDA Issues Two Warning Letters to Leading Manufacturer of Endoscopes [01/10/2023] Warning Letters Olympus Medical Systems Corporation Warning Letter [10/07/2026] Olympus Medical Systems Corporation Warning Letter (Hinode) [03/15/2023] Olympus Medical Systems Corporation Warning Letter (Hachioji-shi) [12/12/2022] Aizu Olympus Warning Letter [11/02/2022] Infections Associated with Reprocessed Duodenoscopes [06/30/2022] Infections Associated with Reprocessed Urological Endoscopes - Letter to Health Care Providers [04/01/2021]
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原文摘录:CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. … Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program
关注理由:这条儿科学资料涉及具体临床问题,研究人群、方法和结局指标可以结合原文进一步查看。
原文摘录:Image credit: © Marcos Osorio/Stocksy | stock.adobe.com Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2026 16 October 2026 Six new medicines recommended for approval; another five medicines recommended for … eu All other enquiries please submit your request via the online form Follow us on Bluesky Related medicine information Foundayo Rasonque Yuviwel Fovlussea Neuzafy Kizfizo Kyinsu Talvey Tukysa Tryngolza Yartemlea Mylotarg Truqap Ibrance
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原文摘录:Disease Outbreak News Middle East respiratory syndrome coronavirus - Kingdom of Saudi Arabia 15 October 2026 See all DONs related to this event Situation at a glance Between 1 January and 5 October 2026, the Kingdom of Saudi Arabia reported eight laborato … int/emergencies/disease-outbreak-news/item/2026-DON618 See all DONs related to this event
原文摘录:Image credit: © Chinnapong | stock.adobe.com EMA recommends authorisation of Rasonque for metastatic pancreatic cancer 15 October 2026 Phased review fast tracks assessment of medicine addressing unmet medical need News Human Innovation Medicines EMA’s hum … eu All other enquiries Please submit your request via the online form Follow us on Bluesky Related medicine information Rasonque
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中国流感流行情况概要(截至2026年 10 月 11 日) ·监测数据显示,本周南方省份流感病毒检测阳性率略有上升、北方省份流感活动低,全国检出流感阳性样本中甲型流感病毒占比67.9%、乙型流感病毒占比32.1%;甲型流感病毒中A(H1N1)pdm09占比16.5%、A(H3N2)占比83.5%,乙型流感病毒均为B(Victoria)系。全国共报告2起流感样病例暴发疫情。
关注理由:这篇公共卫生动态涉及公共卫生信息,阅读时应关注病例定义、时间窗口与数据来源。
原文摘录:Disease Outbreak News Pneumonia of undetermined etiology - Russian Federation 10 October 2026 See all DONs related to this event Situation at a glance On 2 October 2026, WHO became aware through media reports of the death of an employee of the Irkutsk Ant … item/2026-DON620 See all DONs related to this event
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原文摘录:Kalydeco - withdrawal of application for variation to marketing authorisation Application withdrawn The application for a change to this medicine's authorisation has been withdrawn ivacaftor Post-authorisation Human Overview Vertex Pharmaceuticals (Irelan … News on Kalydeco Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2026 18/09/2026 Combination of cystic fibrosis medicines to treat patients with rare mutations 28/02/2025 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 February 2024 23/02/2024 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023 15/09/2023 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 November 2021 12/11/2021 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 March 2021 26/03/2021 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2020 18/09/2020 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2020 24/07/2020 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-30 April 2020 30/04/2020 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2019 18/10/2019 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 October 2018 19/10/2018 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 July 2018 27/07/2018 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 September 2015 25/09/2015 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 June 2014 27/06/2014 More information on Kalydeco Kalydeco This page was last updated on 09/10/2026
关注理由:这条儿科学临床试验动态值得跟踪,后续可结合原文核对试验进度、研究设计与结果披露情况。
原文摘录:Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 October 2026 9 October 2026 Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting News Veterinary CVMP opinions on veterinary medicinal products The Co … eu All other enquiries Please submit your request via the online form Follow us on Bluesky Related medicine information Stemyca Bovilis Lumpyvax
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原文摘录:BACKGROUND: Whether perineal injury severity independently determines postpartum sexual quality of life (SQoL) is unclear. This study evaluated perineal tears and body image as determinants of SQoL and sexual resumption timing. … OASI carries a substantial risk of delayed sexual resumption, warranting dedicated postpartum counseling