The NDA includes a combination of Blenrep with bortezomib plus dexamethasone (BorDex) or pomalidomide plus dexamethasone ...
The BTD was granted based on the interim results of the Phase III DREAMM-7 trial, which met its primary endpoint.
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 ...
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 ...
Since an initial FDA go-ahead in 2020, Sanofi’s Sarclisa has been specifically approved for patients with previously treated ...
Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable.There are approximately more than 180,000 new cases of multiple myeloma ...
The U.S. Food and Drug Administration said on Friday it has approved the use of a drug combination along with Sanofi's ...
Japan's Ministry of Health, Labour and Welfare (MHLW) has accepted for review GSK's new drug application (NDA) for Blenrep (belantamab mafodotin) to treat patients with relapsed or refractory ...
GSK plc (GSK, GSK.L) said that the Center for Drug Evaluation (CDE) of the National Medical Products Administration or NMPA in China ...
Drug maker GSK plc (GSK, GSK.L) announced Tuesday that Blenrep (belantamab mafodotin) combinations in relapsed/refractory multiple ...
for GSK's Blenrep (belantamab mafodotin) combined with bortezomib plus dexamethasone (BorDex) for the treatment of relapsed or refractory multiple myeloma. The BTD aims to accelerate the ...