All updates
All updates
today 32文献与产业新闻精选评分6060 文献与产业新闻评分5050 Regenxbio gene therapy refiling plan derailed by FDA hold over spine MRI findings
文献与产业新闻评分5353 Roche, Eli Lilly net FDA approval for first-of-its-kind Alzheimer’s biomarker blood test
中文产业新闻精选Chinese source评分7070 FDA加速批准首款GSDIa基因疗法Genglycos
顶刊论文（社媒热度）评分5252 FDA Approves Hypertriglyceridemia Drug That May Reduce Pancreatitis Risk.
中文产业新闻Chinese source评分6161 CDE发布CGT药品"先锐计划"征求意见稿：全链条支持、每年最多支持15个品种
中文产业新闻Chinese source评分6666 瑞利珠单抗与恒瑞立康可泮同日获批，治疗阵发性睡眠性血红蛋白尿症
中文产业新闻Chinese source评分6464 恒瑞医药1类新药立康可泮（CFB抑制剂）获批上市
文献与产业新闻评分4040 STAT+: HHS document offers new clues to Kennedy’s vaccine plans
文献与产业新闻评分4848 Spain, Denmark, and U.K. build fast lanes for FIH trials — Back to School 2026
文献与产业新闻评分5151 Denmark, Spain, and the U.K. build fast lanes for FIH trials — Back to School 2026
文献与产业新闻评分4949 STAT+: How a Trump loyalist got the FDA nomination
文献与产业新闻评分4747 Xspray's Dasynoc approval bid foiled again by FDA's manufacturer concerns
文献与产业新闻评分3838 STAT+: FDA approves Ultragenyx gene therapy
文献与产业新闻评分3838 Contrasting legal decisions on gender-affirming care
文献与产业新闻评分3737 STAT+: Pharmalittle: We’re reading about a Regeneron rare disease drug, an Ultragenyx gene therapy, and more
中文产业新闻精选Chinese source评分8181 再生元Garetosmab获FDA批准用于成人FOP，为全球首款激活素A靶向单抗
中文产业新闻精选Chinese source评分7575 国家药监局批准两款创新药上市，分别针对痛风急性发作和阵发性睡眠性血红蛋白尿症
中文产业新闻精选Chinese source评分7373 恒瑞医药口服CFB抑制剂立康可泮胶囊获NMPA批准用于阵发性睡眠性血红蛋白尿症
中文产业新闻精选Chinese source评分7979 恒瑞医药口服补体B因子抑制剂HRS-5965获NMPA批准治疗PNH
中文产业新闻Chinese source评分6767 国家药监局批准三生国健安弗利奇塔单抗注射液上市，适用于成人痛风性关节炎急性发作
中文产业新闻Chinese source评分6161 恒瑞医药CFB抑制剂获批上市，报产至获批不到9个月
中文产业新闻Chinese source评分6666 阿斯利康瑞利珠单抗PNH适应症获NMPA批准 为该药在中国第3项适应症
中文产业新闻精选Chinese source评分6969 三生制药旗下益赛那（SSGJ-613）获NMPA批准上市，用于成人急性痛风性关节炎
中文产业新闻Chinese source评分6666 三生国健安弗利奇塔单抗注射液在华获批上市，用于成人急性痛风发作
中文产业新闻精选Chinese source评分7878 国家药监局批准富马酸立康可泮胶囊（恒优达）上市，用于阵发性睡眠性血红蛋白尿症
中文产业新闻精选Chinese source评分6868 OncoSil Medical P-32 植入装置获 FDA 批准用于不可切除远端胆管癌
中文产业新闻精选Chinese source评分7373 国家药监局批准安弗利奇塔单抗皮下注射剂上市，用于急性痛风性关节炎
中文产业新闻Chinese source评分6161 三生国健安弗利奇塔单抗皮下注射液获NMPA批准上市
中文产业新闻精选Chinese source评分7070 三生国健安弗利奇塔单抗皮下注射剂获NMPA批准 适应症含痛风急性发作
中文产业新闻Chinese source评分6363 君远生物结直肠癌多基因伴随诊断试剂盒获NMPA批准，系全球首个PCR熔解曲线产品
中文产业新闻精选Chinese source评分7575 三生国健抗IL-1β单抗SSGJ-613获NMPA批准上市，用于痛风性关节炎急性发作
文献与产业新闻评分3939 Meet Aletta: The first FDA approved robotic blood draw device
文献与产业新闻精选评分8282 Ultragenyx, after FDA speed bump, lands 1st gene therapy nod with green light in glycogen storage disease
中文产业新闻精选Chinese source评分6868 FDA批准AAV基因疗法DTX401（Genglycos）用于Ia型糖原贮积病
文献与产业新闻评分5858 STAT+: How Trump loyalist Heidi Overton became the president’s pick to run the FDA
文献与产业新闻评分5757 STAT+: New CDC director tells staff she is prepared to speak ‘truth to power’
FDA Press Releases精选评分6969 FDA Approves First Therapy for Patients aged 8 years and older with Glycogen Storage Disease Type Ia
文献与产业新闻精选评分8484 STAT+: Regeneron drug for disease that causes dangerous bone growth earns FDA approval
文献与产业新闻评分5959 Lilly’s long-acting insulin wins NICE blessing ahead of potential UK approval