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

The U.S. Food and Drug Administration has extended its review of GSK's blood cancer drug, Blenrep, as a combination treatment ...

Dow Jones Newswires is a market-moving financial and business news source, used by wealth managers, institutional investors and fintech platforms around the world to identify trading and investing ...

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 ...

London: GSK plc has announced the extension of the US Food and Drug Administration (FDA) review period for the Biologics ...

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

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.

The combinations are also approved for relapsed or refractory multiple myeloma in Japan, the UK and other markets including Switzerland and Canada.

GSK (NYSE:GSK) announced on Thursday that EU regulators approved two combination therapies involving its antibody drug ...

Particularly, momelotinib complements GSK’s new drug, Blenrep/belantamab mafatotin, which was approved for fourth-line multiple myeloma in 2020. Year to date, shares of GSK have gained 0.1% ...

The FDA accepted a BLA for Blenrep combinations for multiple myeloma treatment after prior therapy. DREAMM-7 and DREAMM-8 trials showed significant improvements in progression-free survival and ...