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 ...

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

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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.

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 U.S. Food and Drug Administration has extended its review of GSK's blood cancer drug, Blenrep, as a combination treatment, the company said on Wednesday.

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

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

GSK specialty medicines grew YoY in Q1 2025, and it is now the main profit engine, offsetting the weakness in their vaccine segment. See why the stock is a Buy.

The FDA has accepted for priority review a new supplemental biologics license application for Winrevair to treat adults with advanced pulmonary arterial hypertension, according to a press release ...

(Alliance News) - GSK PLC on Wednesday said the US Food & Drug Administration has extended the review period for Blenrep combinations in relapsed/refractory multiple myeloma after an advisory ...