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The British pharmaceutical company said combinations for its Blenrep drug were evaluated in adults with relapsed or ...
GSK Plc’s blood cancer drug failed to secure the backing of a panel of US regulatory advisers, putting its approval in doubt.
The median progression-free survival was 32.6 months on the Blenrep combo compared to 12.5 months on the alternative. While ...
FDA advisers on Thursday voted against GSK's blood cancer drug Blenrep, finding that its risks outweighed its benefits at the ...
On a quest to bring its multiple myeloma antibody-drug conjugate (ADC) Blenrep back to the U.S. | Members of the FDA's Oncologic Drugs Advisory Committee voiced concerns with ocular toxicity side ...
The U.S. FDA's panel of independent advisers on Thursday recommended against GSK's blood cancer drug Blenrep, citing concerns ...
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 comeback story of belantamab mafodotin (Blenrep) hit a roadblock Thursday as the FDA's Oncologic Drugs Advisory Committee ...
The rough ride presaged by briefing documents came to pass for GSK plc with the drug first approved by the U.S. FDA as Blenrep (belantamab mafodotin, bel-maf), as the agency’s Oncologic Drugs Advisory ...
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 ...
GSK remains confident in Blenrep’s safety and efficacy, and will work with the FDA as it reviews the drug, the company said ...