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An FDA advisory committee ruled in two separate votes that two belantamab mafodotin combination regimens should not be used ...
On a quest to bring its multiple myeloma antibody-drug conjugate Blenrep back to the U.S. | Members of the FDA's Oncologic ...
The FDA's Oncologic Drugs Advisory Committee has casted their votes on the utilization of certain treatments in the multiple ...
The U.S. FDA's panel of independent advisers on Thursday recommended against GSK's blood cancer drug Blenrep, citing concerns ...
GSK has been enjoying regulatory momentum in recent months as it works to bring its antibody-drug conjugate (ADC) Blenrep ...
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GlobalData 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 panelists flagged safety concerns with Blenrep and GSK’s failure to optimize its dosing regimen for the antibody-drug ...
The U.S. Food and Drug Administration's staff reviewers on Tuesday raised safety concerns that GSK's blood cancer drug ...
The U.S. Food and Drug Administration's staff reviewers on Tuesday raised safety concerns that GSK's blood cancer drug ...
The panel expressed concerns about the proposed doses of Blenrep (belantamab mafodotin) in GSK's marketing application, ...
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GlobalData on MSNGSK’s Blenrep faces setback as FDA cancer committee votes against approvalOncologic Drugs Advisory Committee (ODAC) has voted against the benefit/risk profile of GSK’s Blenrep (belantamab mafodotin) ...
The analyst further reasoned that the high ocular toxicity rates, including keratopathy and visual acuity changes, are ...
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