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All updates
today 32监管与产业动态精选评分6565 监管与产业动态评分3333 Signal or noise? > Ultragenyx says EMA validates MPS IIIA application - mugglehead.com >> Comment below! #strategy #competitiveintelligence #marketing #healthcare #pharmaceutical #biotech #competitivemarketing #pharma
中文产业新闻精选Chinese source评分4040 诺和诺德：FIX/FX双抗Denecimig延长FDA审评期
AI × 生物医药Chinese source评分3939 Trump 政府 WISeR 项目用 AI 审批 Medicare 预授权，拒批率与激励结构引发争议
社区讨论（Reddit）评分3838 Novo India: Wegovy Pill Filed for Approval, Potential H1 2027 Launch and Focus on Childhood Obesity and Public-Sector
顶刊论文（社媒热度）评分3636 Impending changes to U.S. human subject protections put ethicists on edge.
中文产业新闻精选Chinese source评分6363 罗氏BTK抑制剂fenebrutinib申报多发性硬化上市并获优先审评
中文产业新闻精选Chinese source评分6868 BMS多发性骨髓瘤新药艾泊度胺获NMPA附条件批准，系全球首款CELMoD药物
中文产业新闻Chinese source评分3434 一封警告信，让费森尤斯卡比股价一天跌近 5%
FDA Drugs评分2323 eCTD Submission Standards for eCTD v4.0 and Regional M1
FDA Drugs评分1212 Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act
FDA Drugs精选评分7474 FDA approves pirtobrutinib for previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma
FDA Drugs评分5050 Oncology (Cancer)/Hematologic Malignancies Approval Notifications
社区讨论（Reddit）评分2929 Newsom moves to make GLP-1 drugs cheaper for California residents
FDA Drugs精选评分5151 Transparency Makes Modern Regulatory Science Stronger — FDA’s Transparency Roadmap
FDA Drugs评分2828 Webinar for Stakeholder Engagement on the New Final Guideline on General Principles for Model-Informed Drug Development (ICH M15) - 10/29/2026
FDA Drugs评分99 Untitled Letters
中文产业新闻精选Chinese source评分6666 FDA 批准 Ultragenyx 基因疗法 rebisufligene etisparvovec 用于 MPS IIIA 儿童患者
中文产业新闻Chinese source评分6565 首个CELMoD药物艾泊度胺获NMPA附条件批准，联合方案用于复发难治多发性骨髓瘤
EMA News评分1919 Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 September - 1 October
STAT News评分3333 STAT+: NIH awarded all its grant funding, but delayed and opaque decisions stymied researchers
监管与产业动态评分2121 Regulatory tracker: FDA green lights Camzyos in kids; J&J blocks Simponi biosimilars - Fierce Pharma
Cancer Discovery精选评分8080 In Regulatory First, Myeloma Drug Approved Based on MRD Negativity
监管与产业动态评分1010 DIA and MHRA announce speaker line-up for inaugural global summit
监管与产业动态评分2929 MHRA joins global regulators in call to advance alternatives to animal testing
FDA Drugs评分66 Prescription Drug User Fee Amendments
FDA Drugs评分1717 Over-The-Counter Monograph Drug User Fee Program (OMUFA)
FDA Drugs评分99 Human Drug Compounding Outsourcing Facility Fees
FDA Drugs评分1010 GDUFA Paid Facilities List
FDA Press Releases精选评分5454 FDA Approves First Heart Valve Designed to Grow with Children
The Lancet Oncology评分3232 [News] New UK National Cancer Board
The Lancet Oncology评分3030 [News] Viet Nam considers health insurance for cancer screening
EMA News评分1616 Executive Director speech at EMA women’s health multi-stakeholder workshop
EMA News评分3737 Global regulators call for advancing alternatives to animal testing across the medicine lifecycle
EMA News评分3030 EMA Management Board: highlights of September 2026 meeting
EMA News评分2424 Advice on ‘end-of-year’ submission dates for type I variations in 2026
BioPharma Dive精选评分5353 HHS kicks off new programs to speed clinical trials as Chinese competition looms
Endpoints News评分1414 United Therapeutics' legal victory; BMS' Camzyos approved for kids
FDA Drugs评分2020 Newly Added Guidance Documents
FDA Drugs评分1717 Generic Drug User Fee Amendments