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

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 ...

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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 ...

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

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

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.

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 ...

The MAA for the Blenrep combo was supported by interim results from the phase III DREAMM-7 and DREAMM-8 studies, both of which met their primary endpoints of progression-free survival (PFS).