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 (GSK) stock slips as FDA advisors vote against the approval of a combination regimen involving thecompany's blood cancer drug Blenrep. Read more here.

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

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

However, yesterday GSK announced that the FDA has extended the review period for Blenrep to give the agency time to review ...

FDA extends Blenrep combo review to October to assess more data from Phase 3 trials in relapsed or refractory multiple myeloma.

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

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

The pharmaceutical company said it remained confident in the benefit and risk profile of Blenrep and will continue to work ...

GSK Plc shares tumbled after its blood cancer drug failed to secure the backing of a panel of US regulatory advisers, putting ...

Just when the future looked bleak for GSK’s Blenrep comeback in the U.S., the FDA has blessed the company's multiple myeloma ...

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