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GSK said the U.S. Food and Drug Administration extended its review period for Blenrep combinations to treat patients with relapsed or refractory multiple myeloma.
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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.
Roche and Genentech were unable to sufficiently demonstrate the benefit of using Columvi in an earlier treatment setting for ...
Most Oncologic Drugs Advisory Committee members took issue with the lack of dosing optimization and the lack of US patient ...
Discover the latest breakthroughs in oncology, including pivotal FDA decisions, promising therapies, and new treatment options for multiple myeloma and ovarian cancer.
The analyst further reasoned that the high ocular toxicity rates, including keratopathy and visual acuity changes, are ...
The FDA oncologic drugs advisory committee voted against the approval of GSK’s blood cancer treatment Blenrep, delivering a setback to the drugmaker’s efforts to reintroduce the drug to the U.S.
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 US Food and Drug Administration’s (FDA’s) Oncologic Drugs Advisory Committee (ODAC) has voted against the benefit/risk ...
In a surprise, a FDA advisory panel voted that risks tied to a GSK blood cancer drug called Blenrep outweighed the benefits ...