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

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

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

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

In briefing documents released ahead of an Advisory Committee meeting this week, FDA staffers cited safety risks related to a ...

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

GSK's blood cancer drug, Blenrep, is under the U.S. Food and Drug Administration (USFDA) spotlight, as staff reviewers raised ...

Despite the setback with the Oncologic Drugs Advisory Committee vote, GSK emphasizes the unmet need in multiple myeloma and ...

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

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 ...

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

The U.S. FDA's panel of independent advisers on Thursday recommended against GSK's blood cancer drug Blenrep, citing concerns ...