All updates
All updates
today 28监管与产业动态评分4545 监管与产业动态精选评分7474 MHRA approves catumaxomab to treat cancer-related fluid build-up in the abdomen
监管与产业动态评分5151 Novartis' Rhapsido tackles 2 most common forms of chronic hives with swift FDA expansion - Fierce Pharma
监管与产业动态精选评分6161 NHS labs fail to share data vital for diagnosis and care of rare diseases, investigation finds
FDA Drugs评分4141 Recently Issued Guidance Documents
STAT News精选评分6868 Trump administration proposes $70,000 fee for popular international student work program
中文产业新闻Chinese source评分6262 Glycomine旗下GLM101获FDA突破性疗法认定，用于治疗PMM2-CDG
FDA Drugs精选评分8080 FDA approves tucatinib with trastuzumab and pertuzumab for the maintenance treatment of HER2-positive breast cancer
FDA Drugs精选评分5555 Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing
STAT News精选评分6262 STAT+: PhRMA sues over Trump policy mandating lower drug prices in Medicare
FDA Drugs评分4040 Rare Disease Drug Approvals
中文产业新闻Chinese source评分3838 CD19 CAR-T治疗成人B细胞非霍奇金淋巴瘤管理实践专家共识（2025版）
STAT News精选评分5555 STAT+: Justice Department targets drugmakers in new directive on combating white-collar fraud
监管与产业动态评分4141 Government backs recommendations of NHS doctors-led AI Commission
监管与产业动态评分1919 How NIH’s Nicole Kleinstreuer is working to reduce animal testing while avoiding a ‘backlash’ - Fierce Biotech
监管与产业动态评分3232 UK unveils new policy to constantly monitor AI-based medical devices - Fierce Biotech
监管与产业动态评分3737 Proposed nuclear safety rules threaten to stall Novartis’ Pluvicto expansion - Fierce Pharma
监管与产业动态评分2323 ViiV girds data package for Cabenuva in competitive HIV treatment market - Fierce Pharma
监管与产业动态精选评分4444 Abbott nabs FDA approval for new CardioMEMS HF System that allows heart readings to be seen at home - Fierce Biotech
中文产业新闻精选Chinese source评分7575 艾伯维帕金森新药tavapadon获FDA批准上市，为全球首款选择性D1/D5受体部分激动剂
FDA Drugs评分3939 Competitive Generic Therapy Approvals
中文产业新闻Chinese source评分6262 罗氏 fenebrutinib 获 FDA 受理并优先审评，覆盖 RMS 与 PPMS
JAMA精选评分7878 FDA Authorizes First Autonomous Robotic Blood Draw Device
BioSpace精选评分4848 FDA extends review of Novo’s hemophilia A drug, citing manufacturing issues
STAT News评分2626 STAT+: FDA spells out 2027 AI guidance plans
FDA Drugs评分4444 Online Generic Medicine/www.onlinegenericmedicine.com - 737806 - 09/23/2026
FDA Drugs精选评分4646 TCI Co., Ltd BioCosme PABP BRANCH - 736888 - 09/02/2026
FDA Drugs评分3737 Cheap Medicine Shop/www.cheapmedicineshop.com - 737810 - 09/24/2026
FDA Drugs评分4646 Pine Pharmaceuticals, LLC - 728537 - 08/07/2026
FDA Drugs精选评分5555 Walmart, Inc. - 736557 - 10/01/2026
FDA Drugs评分4141 Aidance Scientific, Inc. - 735346 - 10/01/2026
FDA Drugs评分4242 The Platinum Healthcare LLC - 735147 - 10/01/2026
FDA Drugs评分3131 Graceful Touch, LLC - 735272 - 10/01/2026
FDA Drugs评分4545 DesBio/Deseret Biologicals, Inc. - 735464 - 10/01/2026
FDA Drugs评分3535 Terramed - 735070 - 10/01/2026
FDA Drugs评分4545 Bioactive Services USA, LLC / Herstat Inc. - 734784 - 10/01/2026
FDA Drugs评分3636 RoyceDerm LLC - 734781 - 10/01/2026
FDA Drugs精选评分5656 Amazon.com, Inc. - 736006 - 10/01/2026
FDA Drugs评分4545 OrganiCare, LLC / OrganiCare Nature’s Science, LLC - 734925 - 10/01/2026
中文产业新闻Chinese source评分6363 睿璟生物NGS平台BRAF/TERT/RET/NTRK3基因突变检测试剂盒获批用于甲状腺癌检测