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GSK's blood cancer drug gets EU approval
(Reuters) -The European Union has approved GSK's drug Blenrep to treat relapsed or treatment-resistant forms of a cancer affecting blood plasma cells ... GSK said. The approval comes a day after the U ...
GSK (NYSE:GSK) announced on Thursday that EU regulators approved two combination therapies involving its antibody drug conjugate, Blenrep, developed with Pfizer (PFE) and Kyowa Kirin (OTCPK:KYKOF) ...
The pharmaceutical company said it remained confident in the benefit and risk profile of Blenrep and will continue to work with the FDA.
The U.S. Food and Drug Administration has extended its review of GSK's blood cancer drug, Blenrep, as a combination treatment ...
The U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of GSK plc’s (NYSE: GSK) Blenrep ...
The British pharmaceutical company said combinations for its Blenrep drug were evaluated in adults with relapsed or refractory multiple myeloma who have previously received at least one line of ...
In a surprise, advisers to the Food and Drug Administration on Thursday voted that the risks tied to a blood cancer drug from GSK outweighed the benefits it had demonstrated in trials, as concerns ...
GSK (GSK) stock slips as FDA advisors vote against the approval of a combination regimen involving thecompany's blood cancer drug Blenrep. Read more here.
The U.S. Food and Drug Administration's staff reviewers on Tuesday raised safety concerns that GSK's blood cancer drug Blenrep, when used in combination with other treatments, may cause eye damage in ...
GSK's Nucala is a monoclonal antibody that inhibits interleukin-5, which helps regulate eosinophils, a type of white blood cell that causes inflammation in the lungs when overproduced.
The FDA oncologic drugs advisory committee voted against the approval of GSK’s blood cancer treatment Blenrep, delivering a setback to the drugmaker’s efforts to reintroduce the drug to the U ...
The Food and Drug Administration's oncologic drugs advisory committee voted against approval of GSK's blood cancer drug Blenrep. The British pharmaceutical company said Thursday combinations for ...
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