智通财经APP获悉，GSK (GSK.US) 日前宣布，美国FDA已授予其PD-1抑制剂Jemperli (dostarlimab)用于治疗局部晚期错配修复缺陷 (dMMR)/高微卫星不稳定性 (MSI-H)直肠癌的突破性疗法认定 (BTD)。

▎药明康德内容团队编辑GSK日前宣布，美国FDA已授予其PD-1抑制剂Jemperli（dostarlimab）用于治疗局部晚期错配修复缺陷（dMMR）/高微卫星不稳定性（MSI-H）直肠癌的突破性疗法认定（BTD）。根据新闻稿，这是dostarli ...

In one of the final steps before a marketing authorization decision by the European Medicines Agency, it recommended ...

In one of the final steps before a marketing authorization decision by the European Medicines Agency, it recommended ...

GSK plc’s GSK HIV subsidiary, ViiV Healthcare announced that the Europe Medicines Agency’s (“EMA”) Committee for Medicinal ...

Jemperli是一种抗PD-1抗体，是GSK免疫肿瘤学研究和开发的基础。它目前在美国获批用于某些类型的子宫内膜癌，并在加速批准下用于dMMR复发或晚期实体瘤，继续批准取决于确证性试验的验证。本报告基于GSK plc的新闻稿。

在日本，GSK的呼吸道合胞病毒（RSV）疫苗Arexvy已获批用于50-59岁成年人。公司还报告了linerixibat的第三阶段GLISTEN试验的积极结果，该药物旨在治疗原发性胆汁性胆管炎患者的胆汁淤积性瘙痒。然而，由于预期2025年增长将趋于平缓，Jefferies和Guggenheim的金融分析师已下调了GSK的股票评级。

GSK (GSK) announced that the US Food and Drug Administration, FDA, has granted Breakthrough Therapy Designation, BTD, for ...

GSK (GSK) announced the Committee for Medicinal Products for Human Use, CHMP, of the European Medicines Agency, EMA, has recommended expanding ...

GSK's cancer drug Jemperli cleared an important hurdle ahead of potentially expanding its European Union marketing permission, in a boost to the pharmaceutical giant's oncology pipeline. The British ...