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The U.S. Food and Drug Administration's panel of independent advisers voted on Thursday against approval of GSK's blood ...
GSK has been enjoying regulatory momentum in recent months as it works to bring its antibody-drug conjugate (ADC) Blenrep ...
FDA reviewers have identified high rates of ocular toxicity as GSK looks to place its blood cancer drug back on the market.
The FDA's ODAC voted that the benefit-risk profile of belantamab mafodotin in multiple myeloma were not favorable, highlighting notable ocular toxicities and missed opportunities for dosing ...
The U.S. Food and Drug Administration's staff reviewers on Tuesday raised safety concerns that GSK's blood cancer drug ...
GSK's blood cancer drug, Blenrep, is under the U.S. Food and Drug Administration (USFDA) spotlight, as staff reviewers raised ...
UK pharma major GSK is seeking US approval for Blenrep (belantamab mafodotin) in two multiple myeloma indications.
The FDA is reevaluating GlaxoSmithKline’s blood cancer drug Blenrep following mixed results from two phase 3 trials and mounting concerns about eye-related side effects and dosing. The agency is ...
This summary highlights significant events in the health sector, including Johnson & Johnson's profit boost from Darzalex, safety concerns for GSK's cancer drug, refugee malnutrition in Gaza, KKR's ...
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 ...
Recent developments illustrate dynamic shifts in the healthcare sector. Trump's spending bill is anticipated to challenge ...
BLENREP is a first-in-class anti-BCMA (B-cell maturation antigen) therapy for patients whose disease has progressed despite prior treatment with an immunomodulatory agent, proteasome inhibitor and ...