这是fda批准的首个肿瘤源性T细胞免疫疗法。 Today, the U.S. Food and Drug Administration approved Amtagvi, the first cellular therapy indicated for the treatment of adult patients with a type of skin cancer (melanoma) that is unable to be removed with surgery (unresectable) or has spread to o...
Intra-Cellular Therapies(ICT)是一家专注于开发创新疗法治中枢神经系统(CNS)疾病的生物制药公司。近日,该公司宣布,美国食品和药物管理局(FDA)已批准Caplyta(lumateperone),用于精神分裂症成人患者的治疗。该公司预计,将在2020年第一季度末启动...
Other than what I mentioned above, there was nothing else approved that was an actual stem cell therapy. There were, however, cellular therapies approved even if not related to stem cells. In a way these fit into the broader category of regenerative medicine. Note that you can watch me disc...
参考资料: [1] https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products [2] https://mp.weixin.qq.com/s/3rYWsL8OB4134-h9OfJp7Q [3] https://www.sohu.com/a/651211067_121370844 「2023-04-09期」福利获奖名单 您有哪些益生菌产品...
options,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. “We believe CAPLYTA has the potential to be an important option for patients in the treatment of bipolar depression. We look forward to bringing CAPLYTA to market, if app...
1/21,强生(Johnson & Johnson)已获得FDA批准,其鼻用喷雾药物Spravato(艾司氯胺酮,esketamine)成为首个单药治疗成人难治性抑郁症(TRD)的疗法,适用于对至少两种口服抗抑郁药治疗反应不足的患者。这一批准于周二宣布,正值强生加大对神经科学领域的投入之际,其近期以146亿美元收购Intra-Cellular Therapies的交易更凸显了这...
12月23日,Intra-CellularTherapies宣布FDA批准Caplyta(lumateperone)42mg上市,用于治疗成人精神分裂症。Intra-Cellular计划在2020Q1将Caplyta推向市场。 lumateperone结构式 lumateperone是口服5-HT2A受体拮抗剂,每日1次,其疗效在两项安慰剂对照研究中获得证实,相比安慰剂可以显著改善患者的PANSS量表评分。与安慰剂相比更...
Last week, the Food and Drug Administration (FDA) approved four different therapies in the oncology space — one of which, Amtagvi, marks the first cellular therapy for the treatment of solid cancers. The week’s first approval (an Onivyde regimen for metastatic pancreatic cancer) was covered...
Besides ciltacabtagene autoleucel co-developed by Jassen and Legend Biotech, which was approved last month by the FDA,there are 3 additional gene therapies which could gain FDA approval and another 8 aiming for BLA submissions by the end of the year. ...
Besides ciltacabtagene autoleucel co-developed by Jassen and Legend Biotech, which was approved last month by the FDA,there are 3 additional gene therapies which could gain FDA approval and another 8 aiming for BLA submissions by the end of the year. ...