All updates
All updates
today 32FDA Drugs评分33 FDA Drugs评分1313 Importing Human Drugs
FDA Drugs评分1010 Rare Diseases Team
FDA Drugs评分3737 Public Meeting on the Recommendations for Reauthorization of the Prescription Drug User Fee Act (PDUFA) - 09/16/2026
FDA Drugs评分77 Office of Generic Drugs | Offices and Divisions
FDA Drugs评分2525 C3TI Demonstration Program Frequently Asked Questions (FAQs)
FDA Drugs评分88 What’s New in Clinical Trial Innovation
FDA Drugs评分1313 CDER Center for Clinical Trial Innovation (C3TI)
FDA Drugs评分99 Facilitating Collaboration Across CDER
BioSpace评分4747 US government launches AI-driven programs to overhaul clinical trials
STAT News评分2121 STAT+: Pharmalittle: We’re reading about a plan to lower Medicare drug prices, a Lilly obesity drug, and more
STAT News评分1414 STAT+: A major insurer on how it may replicate Medicare’s chronic-care experiment
BioPharma Dive评分2222 5 FDA decisions to watch in the fourth quarter of 2026
Endpoints News评分1717 Lawmakers hear mixed opinions on psychedelics credentialing
中文产业新闻精选Chinese source评分6161 miv-cel 启动向 FDA 滚动 BLA 申报，冲刺自身免疫适应症 CAR-T
中文产业新闻精选Chinese source评分6565 国家药监局药审中心发布推进新方法研究和应用试点先锋计划
中文产业新闻精选Chinese source评分6262 圣诺生物被 FDA 列入 66-40 号进口警示名单，20 州总检察长向 GLP-1 复合药房施压
中文产业新闻Chinese source评分4949 美国计划减少对中国等地区仿制药和原料药的依赖
中文产业新闻Chinese source评分6060 BMS 艾泊度胺胶囊获 NMPA 附条件批准，联合达雷妥尤单抗和地塞米松治疗多发性骨髓瘤
中文产业新闻精选Chinese source评分4848 艾伯维JUVO™（Tavapadon）获FDA批准上市，系全球首个帕金森病选择性D1/D5受体激动剂
中文产业新闻Chinese source评分2525 Ionis独立商业化大冒险：从Tryngolza到Zanvastro
中文产业新闻Chinese source评分5050 美国拟将86种关键药物生产迁回国内以减少对中国原料药依赖
中文产业新闻精选Chinese source评分6161 BMS的CELMoD药物Iberdomide国内获批，联合方案治疗复发多发性骨髓瘤
文献与产业新闻精选评分5959 I-DXd withdrawal thins October PDUFA calendar
STAT News评分1919 STAT+: Two key Senate health committees face major shake-ups
FDA Drugs评分33 The CDER Reference Guide
FDA Drugs评分1010 Frequently Asked Questions About Drugs
FDA Drugs评分55 CDERLearn
FDA Drugs评分1818 Drug Interactions | Relevant Regulatory Guidance and Policy Documents
FDA Drugs评分11 Guidance Documents: Office of Drug Information
FDA Drugs评分55 Guidances | Drugs
FDA Drugs评分1010 Generic Drugs
FDA Drugs评分33 Drug Safety Information
FDA Drugs评分66 The Bad Ad Program
FDA Drugs评分2929 How to Request Domperidone for Expanded Access Use
FDA Drugs评分66 Drug Safety-related Labeling Changes (SrLC) Database Overview: Updates to Safety Information in FDA-Approved Prescription Drug Labeling
FDA Drugs评分1313 Over-the-Counter (OTC) | Nonprescription Drugs
FDA Drugs评分1010 FDA Drug Info Rounds Video
FDA Drugs评分2525 CDER Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality (CDER Quality Standards Program)
FDA Drugs评分5151 FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss