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 ...

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

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.

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GlaxoSmithKline’s Blenrep combinations for treating relapsed multiple myeloma have been accepted for review by the US FDA, supported by promising results from the DREAMM-7 and DREAMM-8 trials.

The Food and Drug Administration (FDA) accepted a biologics license application (BLA) for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex [BVd]) and ...

GSK plc GSK announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted against the overall benefit/risk ...

Issued: 25 November 2024, London UK Blenrep combinations accepted for review by the US FDA for the treatment of relapsed/refractory multiple myeloma · Regulatory submission supported by phase III ...