The BTD was granted based on the interim results of the Phase III DREAMM-7 trial, which met its primary endpoint.
Japan's MHLW has accepted for review GSK's NDA for Blenrep for patients with relapsed or refractory multiple myeloma.
今日(9月2日),中国国家药监局(NMPA)药品审评中心(CDE)官网新公示,葛兰素史克(GSK)申报的注射用belantamab ...
Drug maker GSK plc (GSK, GSK.L) announced Tuesday that Blenrep (belantamab mafodotin) combinations in relapsed/refractory multiple ...
Blenrep (belantamab mafodotin) in combination receives Breakthrough Therapy Designation in China for treatment of relapsed/refractory multiple myeloma Granted based on results from phase III head ...
Japan’s MHLW accepts for review GSK’s NDA for Blenrep combinations in relapsed/refractory multiple myeloma: London, UK Wednesday, September 18, 2024, 10:00 Hrs [IST] GSK plc a ...
The trial evaluated Blenrep (belantamab mafodotin), in combination with pomalidomide plus dexamethasone (PomDex), versus a standard of care, bortezomib plus PomDex. A pre-specified interim ...
MHLW also has granted orphan drug designation for Blenrep, which reflects the high unmet medical need and ensures priority NDA review in multiple myeloma. This is the third major regulatory filing ...
GSK plc (GSK, GSK.L) said that the Center for Drug Evaluation (CDE) of the National Medical Products Administration or NMPA in China ...
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While Blenrep has been granted accelerated approval by the FDA for multiple myeloma patients who have received at least four prior therapies – including an anti-CD38 monoclonal antibody, a ...
In June 2024, BioWorld covered 221 clinical trial updates, compared to 298 in May. BioWorld recorded 23 phase III trial successes in June, seven failures, and one with mixed results.