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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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GSK plc GSK reported second-quarter 2025 core earnings of $1.23 per American depositary share (ADS), which beat the Zacks ...
FDA extends Blenrep combo review to October to assess more data from Phase 3 trials in relapsed or refractory multiple myeloma.
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 (GSK) stock in focus as the company secures EU approval for Blenrep combo therapies targeting the blood cancer multiple ...
The Food and Drug Administration (FDA) has extended the review period for elinzanetant, an investigational hormone-free therapy for the treatment of moderate to severe vasomotor symptoms (VMS) due to ...
The combinations are also approved for relapsed or refractory multiple myeloma in Japan, the UK and other markets including ...
GSK plc GSK announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted against the overall benefit/risk ...