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FDA reviewers have identified high rates of ocular toxicity as GSK looks to place its blood cancer drug back on the market.
UK pharma major GSK is seeking US approval for Blenrep (belantamab mafodotin) in two multiple myeloma indications.
GSK's blood cancer drug, Blenrep, is under the U.S. Food and Drug Administration (USFDA) spotlight, as staff reviewers raised ...
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 ...
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 ...
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 ...
David Mulligan, PhD, previews the FDA's ODAC meeting discussing the application of belantamab mafodotin-based combinations for the treatment of multiple myeloma.
From my colleague Drew Joseph: Ahead of an advisory committee meeting Thursday focused on GSK’s multiple myeloma drug Blenrep, the FDA pointed to concerns about the high rates of eye issues that have ...
Recent developments illustrate dynamic shifts in the healthcare sector. Trump's spending bill is anticipated to challenge ...
FDA reviewers said in briefing documents that the benefit-risk profile of the drug for the treatment of multiple myeloma “remains unclear.” ...
Shares in US healthcare conglomerate Johnson & Johnson rose by 6% during Wednesday morning’s trading after the presentation ...
The National Cancer Institute-funded study, which will include up to 24,000 people, will screen for a variety of cancers. More news is on dogs detecting Parkinson's; progress in the Influenza Vaccines ...