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相关临床试验
19
11 进行中
药物批准
0
批准总数
监管机构
监管机构数
成立时间
N/A
进行中（未招募）
11
57.9%
已完成
6
31.6%
终止
2
10.5%
暂无批准数据
- The FDA has accepted Ayrmid Ltd.'s priority review application for omidubicel as a treatment for severe aplastic anemia, with a PDUFA target action date of December 10, 2025. - Omidubicel is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from umbilical cord blood, already approved under the brand name Omisirge for hematologic malignancies. - Severe aplastic anemia affects 2-3 individuals per million and represents a significant unmet medical need for patients without matched sibling donors for transplantation. - The supplementary Biologics License Application is based on results from an investigator-sponsored study conducted at the National Heart, Lung, and Blood Institute of the National Institutes of Health.
