News

The new target action date for Blenrep, which GSK is proposing for the second-line treatment of relapsed or refractory multiple myeloma, is Oct. 23.
Last week, an FDA advisory committee against the risk-benefit profile of Blenrep in combination with other therapies. Regulators and reviewers were concerned about the ocular side effects and dosing ...
The US Food and Drug Administration (FDA) has extended the review period for the Biologics License Application (BLA) for ...
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 ...
FDA extends Blenrep combo review to October to assess more data from Phase 3 trials in relapsed or refractory multiple myeloma.
FDA advisers on Thursday voted against GSK's blood cancer drug Blenrep, finding that its risks outweighed its benefits at the ...
The US Food and Drug Administration’s (FDA’s) Oncologic Drugs Advisory Committee (ODAC) has voted against the benefit/risk ...
The anemia treatment missed its main goal in a myelofibrosis study. Meanwhile, Blenrep's return to the U.S. market may have ...
The panel expressed concerns about the proposed doses of Blenrep (belantamab mafodotin) in GSK's marketing application, ...
The U.S. Food and Drug Administration has extended its review of GSK's blood cancer drug, Blenrep, as a combination treatment ...
However, yesterday GSK announced that the FDA has extended the review period for Blenrep to give the agency time to review ...