GSK (GSK) stock in focus as the FDA staff raise safety concerns over Blenrep combo for multiple myeloma ahead of an AdCom ...

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

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

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.

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

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

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

GSK’s attempt to relaunch Blenrep was blocked by FDA advisers due to poor clinical benefit, safety concerns, and eye-related ...

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

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

GSK remains confident in Blenrep’s safety and efficacy, and will work with the FDA as it reviews the drug, the company said ...