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Just when the future looked bleak for GSK’s Blenrep comeback in the U.S., the FDA has blessed the company's multiple myeloma ...
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Pharmaceutical Technology on MSNGSK’s Blenrep US comeback hindered by eye safety concernsFDA reviewers have identified high rates of ocular toxicity as GSK looks to place its blood cancer drug back on the market.
The panel expressed concerns about the proposed doses of Blenrep (belantamab mafodotin) in GSK's marketing application, ...
GSK has been enjoying regulatory momentum in recent months as it works to bring its antibody-drug conjugate (ADC) Blenrep ...
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.
Briefing documents were disclosed relating to the meeting of the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC), which will convene July 17 on the matter of London-based GSK plc’s Blenrep ...
GSK has failed to win the backing of influential advisers to the US drugs regulator for a key blood cancer drug, putting its ...
Reckitt agrees sale of Cillit Bang division 07:25 , Graeme Evans A portfolio of Reckitt Benckiser ...
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 anemia treatment missed its main goal in a myelofibrosis study. Meanwhile, Blenrep's return to the U.S. market may have ...
In a surprise, a FDA advisory panel voted that risks tied to a GSK blood cancer drug called Blenrep outweighed the benefits ...
GSK plc’s Blenrep (belantamab mafodotin) is heading back to the market three years after being withdrawn, with the EMA’s Committee for Medicinal Products for Human Use recommending approval of the ...
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