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 ...

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 ...

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 ...

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.

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

GSK announces the FDA's extension of the review period of its new drug application for momelotinib to treat myelofibrosis by three months. A decision is now expected on Sep 16, 2023.

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 ...

GSK (GSK) announced the US Food and Drug Administration, FDA, has accepted for review a Biologics License Application, BLA, for Blenrep in combinations with bortezomib plus dexamethasone and ...