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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.
GSK has been enjoying regulatory momentum in recent months as it works to bring its antibody-drug conjugate (ADC) Blenrep ...
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 ...
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 ...
Recent developments illustrate dynamic shifts in the healthcare sector. Trump's spending bill is anticipated to challenge ...
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 ...
Blenrep is approved for the treatment of adults with multiple myeloma in combination with bortezomib plus dexamethasone (BVd) in patients who have received at least one prior therapy, and in ...
PDUFA date nears for GSK plc’s Blenrep (belantamab mafodotin), the U.S. FDA’s Oncologic Drugs Advisory Committee will decide July 17 on whether available data justify the return to market of the ...
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