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The European Union has approved GSK's drug Blenrep to treat relapsed or treatment-resistant forms of a cancer affecting blood plasma cells, the British drugmaker said on Thursday.
Last week, an FDA advisory committee against the risk-benefit profile of Blenrep in combination with other therapies. Regulators and reviewers were concerned about the ocular side effects and dosing ...
The new target action date for Blenrep, which GSK is proposing for the second-line treatment of relapsed or refractory multiple myeloma, is Oct. 23.
(Alliance News) - GSK PLC on Wednesday said the US Food & Drug Administration has extended the review period for Blenrep combinations in relapsed/refractory multiple myeloma after an advisory ...
The FDA has declined to approve Columvi, in combination with the chemo regimen GemOx, for the treatment of second-line DLBCL ...
Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of GSK plc’s ...
In a surprise, a FDA advisory panel voted that risks tied to a GSK blood cancer drug called Blenrep outweighed the benefits ...
The FDA's Oncologic Drugs Advisory Committee has casted their votes on the utilization of certain treatments in the multiple ...
The anemia treatment missed its main goal in a myelofibrosis study. Meanwhile, Blenrep's return to the U.S. market may have ...
The FDA has approved GSK's Shingrix vaccine (recombinant zoster vaccine or RZV) in a prefilled syringe presentation to prevent shingles.
GSK’s attempt to relaunch Blenrep was blocked by FDA advisers due to poor clinical benefit, safety concerns, and eye-related side effects.
The FDA's ODAC voted that the benefit-risk profile of belantamab mafodotin in multiple myeloma were not favorable, ...
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