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The FDA oncologic drugs advisory committee voted against the approval of GSK’s blood cancer treatment Blenrep, delivering a setback to the drugmaker’s efforts to reintroduce the drug to the U.S.
GSK Plc (NYSE:GSK) stock fell 5% after a U.S. Food and Drug Administration advisory panel voted against recommending approval for its blood cancer drug Blenrep, citing concerns that risks outweigh ...
The US Food and Drug Administration’s (FDA’s) Oncologic Drugs Advisory Committee (ODAC) has voted against the benefit/risk ...
Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of GSK plc’s ...
FDA advisers on Thursday voted against GSK's blood cancer drug Blenrep, finding that its risks outweighed its benefits at the ...
An FDA advisory committee ruled in two separate votes that two belantamab mafodotin combination regimens should not be used ...
Move is another oncology setback for GSK Drug had gained accelerated U.S. approval in certain cases Trials of the drug to continue Blenrep achieved $105 million in global sales last year Nov 22 ...
"GSK remains confident in the benefit/risk profile of Blenrep and will continue to work closely with the FDA as they complete their review for Blenrep in patients with relapsed or refractory multiple ...
The pharmaceutical company said it remained confident in the benefit and risk profile of Blenrep and will continue to work ...
The panel expressed concerns about the proposed doses of Blenrep (belantamab mafodotin) in GSK's marketing application, ...
In a surprise, a FDA advisory panel voted that risks tied to a GSK blood cancer drug called Blenrep outweighed the benefits ...
On a quest to bring its multiple myeloma antibody-drug conjugate Blenrep back to the U.S. | Members of the FDA's Oncologic ...