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21 小时
血霁生物XJ-MK-002获FDA儿科罕见病资格认定|北极光·Family
10月18日,北极光投资企业 血霁生物 宣布自主研发的“全球新” Fisrt-in-Class细胞治疗产品XJ-MK-002 治疗先天性无巨核细胞性血小板减少症获得美国食品药品监督管理局(FDA)认证授予儿科罕见病资格认定(Rare ...
wap.stockstar
1 天
21健讯Daily|因肺癌药物合作纠纷,复星医药子公司请求仲裁艾力斯 ...
(原标题:21健讯Daily|因肺癌药物合作纠纷,复星医药子公司请求仲裁艾力斯支付约2.55亿元;国家药监局部署开展生物制品分段生产改革试点) 这里是《21健讯Daily》,欢迎与21世纪经济报道新健康团队共同关注医药健康行业最新事件!
21经济网
1 天
国家药监局部署开展生物制品分段生产改革试点
近几年,国家医保局采取一系列措施,切实提升罕见病患者的医疗保障水平。初步统计,80余种罕见病用药已被纳入现行医保药品目录。同时,完善准入程序,及时将符合条件的罕见病用药纳入医保目录,建立每年一次的动态调整机制,为罕见病用药设置单独的申报条件;在评审、测算、谈判环节,予以罕见病用药支持和倾斜政策,让更多新获批上市的罕见病用药有机会更快进入医保目录。
Managed Healthcare Executive
1 天
A New Type of Gene Therapy Shows Promise for Treating Retinitis Pigmentosa
Up to half of patients showed significant improvement in study results presented at the American Academy of Ophthalmology ...
Managed Healthcare Executive
3 天
Cancer’s Reign Over the Drug Development Pipeline Continues| AMCP Nexus 2024
The FDA has already made more than a dozen cancer drug approval decisions this year and more expected in the next several ...
PipelineReview.com
3 天
Tenaya Therapeutics Announces Updates on TN-201 Gene Therapy Program for MYBPC3-associated HCM
Independent Data Safety and Monitoring Board Endorsed Dose Escalation and Broadening of Eligibility Criteria; Cohort 2 Now Enrolling ...
Targeted Oncology
4 天
FDA Grants Rare Pediatric Disease Designation to Galinpepimut-S in AML
The FDA granted galinpepimut-S a rare pediatric disease designation for the treatment of pediatric patients with acute ...
Cancer Therapy Advisor
4 天
Galinpepimut-S Gets Rare Pediatric Disease Designation for AML
The FDA grants rare pediatric disease designation for serious or life-threatening diseases that affect fewer than 200,000 people in the United States when those people are primarily younger than 18 ...
EuropaWire
5 天
AstraZeneca Presents New Data at IDWeek 2024, Showcasing Progress in Respiratory Disease ...
AstraZeneca presented significant advancements in the prevention of infectious diseases at IDWeek 2024, showcasing its ...
manilatimes
5 天
Theriva Biologics Announces Orphan Medicinal Product Designation Granted by the European ...
Theriva Biologics (NYSE American: TOVX), ("Theriva” or the "Company”), a clinical-stage company developing therapeutics ...
6 天
SELLAS' Galinpepimut-S Gets Rare Pediatric Disease Designation For Treatment Of Pediatric AML
SELLAS Life Sciences Group, Inc. (SLS), a late-stage clinical biopharmaceutical company, Tuesday announced that the U.S. Food and ...
The Bakersfield Californian
6 天
SELLAS Announces U.S. FDA Rare Pediatric Disease Designation (RPDD) Granted to Galinpepimut ...
GPS Currently Investigated in Phase 3 REGAL Trial in Adult AML Patients – Interim Analysis Anticipated in Q4 2024 - ...
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