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

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.

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.

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

The US Food and Drug Administration’s (FDA’s) Oncologic Drugs Advisory Committee (ODAC) has voted against the benefit/risk ...

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

The FDA's Oncologic Drugs Advisory Committee has casted their votes on the utilization of certain treatments in the multiple ...

With the FDA accepting the BLA for review, a decision from the regulatory body is expected on July 23, 2025. Year to date, shares of GSK have lost 7.9% compared with the industry’s 9% decline.

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 ...