FDA突破性疗法认证(BTD)5周年小结 CDE发布《创新药物临床试验中临床药理学研究的一般考虑》 国内双特异性抗体研发概述 眼科药物非临床研究的考虑 异军突起的纳米抗体药物 明星抗癌药紫杉醇:跌宕起伏的研发故事 魔力再现:ADC抗体药物进展显著 制剂过程中发生晶型转变的风险因素以及机制 史上销售额最高的一类...
根据FDA的审评政策，突破性疗效BTD是有希望获得优先审评的，这个得看临床结果是否支持预期的良好临床疗效。
根据FDA的审评政策，突破性疗效BTD是有希望获得优先审评的，这个得看临床结果是否支持预期的良好临床疗效。
/metastatic nasopharyngeal carcinoma was granted the Breakthrough Therapy Designation (BTD) by the FDA in September 2020. In December 2020, Toripalimab was included in the updated National Reimbursement Drug List (NRDL) (2020 Edition). About Combination Clinical Trial The Combination Clinical Trial is...
/PRNewswire/ -- Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted TAR-200 Breakthrough Therapy Designation (BTD)...
A BTD is for a device that is intended for a life-threatening or irreversibly debilitating disease or condition, while a STeP is for a device targeting a disease or condition that does not meet this qualification (i.e., a less severe disease or condition). A request for such a ...
June 1, 2021 (RARITAN, N.J.)– The Janssen Pharmaceutical Companies ofJohnson & Johnsonannounced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for teclistamab in the treatment of relapsed o...
[2]Today’s approval follows the FDA’s decision to grant Breakthrough Therapy Designation (BTD) in March 2020 and to initiate a Priority Review of the Biologics License Application (BLA) in December 2020. Th...
clinical study evaluating RYBREVANTTMas a monotherapy in patients enrolled in the prior platinum containing chemotherapy cohort.1,10Initial results from the CHRYSALIS EGFR exon 20 insertion mutation population, which supported...
Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for teclistamab in the treatment of relapsed or refractory multiple myeloma. This distinction for teclistamab, an off-the-shelf, T-cell redir...