FDA reviewers have identified high rates of ocular toxicity as GSK looks to place its blood cancer drug back on the market.

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 ...

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 ...

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 ...

The U.S. Food and Drug Administration's staff reviewers on Tuesday raised safety concerns that GSK's blood cancer drug ...

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 ...

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 ...

The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday authorized GSK plc’s (NYSE:GSK) Blenrep. Blenrep is approved for the treatment of adults with multiple myeloma ...

The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday authorized GSK plc’s (NYSE:GSK) Blenrep. Blenrep is approved for the treatment of adults with multiple myeloma ...