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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.
The U.S. Food and Drug Administration's staff reviewers on Tuesday raised safety concerns that GSK's blood cancer drug ...
GSK has been enjoying regulatory momentum in recent months as it works to bring its antibody-drug conjugate (ADC) Blenrep ...
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 ...
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 ...
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 ...
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 ...
GSK specialty medicines grew YoY in Q1 2025, and it is now the main profit engine, offsetting the weakness in their vaccine ...
The offering, the first IPO this year, attracted more than 32 billion dirhams ($3.5 bln) in demand for 500 million dirhams in shares. GSK seeks FDA nod for expanded use of RSV vaccine in adults ...