作者: $三生制药(01530)$合作伙伴SOBI的一季报中提到SEL-212的进展:已向FDA提交上市申请且获得快速通道认定。 SEL-212 received FDA fast track designation In March, Sobi received US Food and Drug Administration (FDA) fast track designation for SEL-212 inchronic refractory gout (CRG). SEL-212 is a ...
结果显示,在第12周时,约81%的可评估患者(n = 27)的血清尿酸控制在6 mg/dl以下。而在另一项唯一获FDA批准的尿酸酶治疗研究中,在第16周时,44%的可评估患者的血清尿酸控制在6 mg/dl以下。33%的EULAR数据代表的患者人群,以及27%的在2期研究中接受SEL-212的患者,在治疗后的第一个月内经历痛风发作,在第二到...
Company continues to expect to hold an End-of-Phase 2 meeting with the FDA by year-endGAITHERSBURG, Md., Oct. 15, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune dise...