The US Food and Drug Administration (FDA) is expected to make a Prescription Drug User Fee Act (PDUFA) decision by mid-2025.

Pharma titan GSK has announced that US regulators have accepted for review Blenrep combinations for the treatment of relapsed ...

US FDA accepts for review GSK’s Blenrep combinations for the treatment of relapsed/refractory multiple myeloma: London, UK Tuesday, November 26, 2024, 09:00 Hrs [IST] GSK plc an ...

GlaxoSmithKline (GB:GSK) has released an update.Don't Miss our Black Friday Offers:Unlock your investing potential with TipRanks Premium - Now ...

GSK (GSK) announced the US Food and Drug Administration, FDA, has accepted for review a Biologics License Application, BLA, for Blenrep in combinations with bortezomib plus dexamethasone and ...

在抗肿瘤药物研发的复杂舞台上，Blenrep的故事宛如一出跌宕起伏的戏剧。曾几何时，这款靶向BCMA的抗体药物被视为GSK重返癌症领域的利器，然而，市场的残酷和临床试验的不确定性让它经历了一波三折的命运。对于许多人来说，Blenrep的退市似乎意味着它的终章，但就在GSK即将放弃时，新的希望又重新燃起。在临床试验DREAMM-7的中期分析显示出积极结果时，这款产品又重新回到了公众的视野中。

第15届医博会期间，同写意生物医药新基建链盟将举办ADC专场，邀请抗体/ADC研发端、生产端和供应链端的企业负责人与会深度交流，帮助行业优化和提升生物药创新生态链。

(Alliance News) - GSK PLC said on Monday that the US Food & Drug Administration accepted a biologics license application for its Blenrep combinations for the treatment of relapsed and refractory ...

Blenrep, which is predicted by analysts to produce revenues of around $1.5bn in 2026, is an antibody-drug conjugate that works by targeting B-cell maturation antigen (BCMA), a protein commonly ...

GSK's drive to resurrect its multiple myeloma therapy Blenrep has continued with new data from the DREAMM-7 trial showing an increase in overall survival (OS) with the drug had reached statistical ...

已经撤市的Blenrep，曾被视为GSK重回肿瘤战场的一把利器。无论是BCMA这个靶点，还是ADC这一分子类型，这款产品过去都因为抗肿瘤方面的潜力而名声 ...

The key secondary end point of overall survival (OS) was met in the DREAMM-7 trial of belantamab mafodotin (Blenrep; GSK) for the treatment of patients with relapsed/refractory multiple myeloma (R/R ...