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GSK, Jemperli

GSK announces FDA granted BTD for Jemperli

GSK (GSK) announced that the US Food and Drug Administration, FDA, has granted Breakthrough Therapy Designation, BTD, for Jemperli for the treatment of patients with locally advanced mismatch repair deficient/microsatellite instability-high,

Business Insider · 3d

GSK announces CHMP of the EMA recommended expanding approval of Jemperli

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

Sharecast · 3d

GSK's Jemperli recommended for expanded use in Europe, Aussie regulator launches proceedings against Entain

London open The FTSE 100 is expected to open 12 points lower on Monday, having closed down 0.14% on Friday at 8,300.33.

MarketWatch · 3d

GSK Jemperli Gets Positive CHMP Opinion

Dow Jones Newswires is a market-moving financial and business news source, used by wealth managers, institutional investors and fintech platforms around the world to identify trading and investing opportunities, strengthen advisor-client relationships and build investor experiences. Learn More. Back To Top

Zacks.com on MSN · 2d

GSK Gets CHMP Nod for Expanded Use of HIV Combo & Jemperli

GSK plc’s GSK HIV subsidiary, ViiV Healthcare announced that the Europe Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) has rendered a positive opinion recommending marketing authorization for its new long-acting HIV regimen.

3don MSN

GSK’s Cancer Drug Jemperli Moves a Step Closer to European Marketing Permission

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

GSK's Cancer Drug Jemperli Nears EU Marketing Expansion -- 2nd Update

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.

阿思達克財經網7h

GSK(GSK.US)单抗一线疗法获FDA突破性疗法认定用于治疗直肠癌

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)。

GSK的Jemperli获得FDA突破性疗法认定用于治疗直肠癌

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。

MarketWatch3d

GSK's Cancer Drug Jemperli Moves a Step Closer to European Marketing Permission -- Update

GSK's cancer drug Jemperli cleared an important hurdle ahead of potentially receiving marketing permission from the European Medicines Agency. The British pharmaceutical giant said Monday that the ...

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