On a quest to bring its multiple myeloma antibody-drug conjugate Blenrep back to the U.S. | Members of the FDA's Oncologic ...

FDA advisers on Thursday voted against GSK's blood cancer drug Blenrep, finding that its risks outweighed its benefits at the ...

The panelists flagged safety concerns with Blenrep and GSK’s failure to optimize its dosing regimen for the antibody-drug ...

The panel expressed concerns about the proposed doses of Blenrep (belantamab mafodotin) in GSK's marketing application, ...

GSK has been enjoying regulatory momentum in recent months as it works to bring its antibody-drug conjugate (ADC) Blenrep ...

The anemia treatment missed its main goal in a myelofibrosis study. Meanwhile, Blenrep's return to the U.S. market may have ...

An FDA advisory committee ruled in two separate votes that two belantamab mafodotin combination regimens should not be used ...

GSK plc GSK announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted against the overall benefit/risk ...

Most Oncologic Drugs Advisory Committee members took issue with the lack of dosing optimization and the lack of US patient ...

Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of GSK plc’s ...

In a surprise, a FDA advisory panel voted that risks tied to a GSK blood cancer drug called Blenrep outweighed the benefits ...

GSK shares fell more than 6% on Friday to the bottom of Britain's blue-chip index after a U.S. FDA advisory panel recommended ...