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The European Union has approved GSK's drug Blenrep to treat relapsed or treatment-resistant forms of a cancer affecting blood ...
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.
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.
(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 ...
Just when the future looked bleak for GSK’s Blenrep comeback in the U.S., the FDA has blessed the company's multiple myeloma ...
Most Oncologic Drugs Advisory Committee members took issue with the lack of dosing optimization and the lack of US patient ...
The analyst further reasoned that the high ocular toxicity rates, including keratopathy and visual acuity changes, are ...
An FDA advisory committee ruled in two separate votes that two belantamab mafodotin combination regimens should not be used ...
Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of GSK plc’s ...
The anemia treatment missed its main goal in a myelofibrosis study. Meanwhile, Blenrep's return to the U.S. market may have ...
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