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Most Oncologic Drugs Advisory Committee members took issue with the lack of dosing optimization and the lack of US patient ...
The FDA said the GSK drug shrank tumors in 41.6% of patients. Of those responders, 9.1% had a complete response while 32.5% showed a partial response. The median duration of response was 34.7 ...
The U.S. Food and Drug Administration's panel of independent advisers on Friday voted against the efficacy of Otsuka Pharma's ...
FDA takes tougher line on fast-tracked drugs GSK, Roche pull drugs previously approved on an accelerated basis, while other firms win speedy approvals only after starting confirmatory studies ...
The FDA approved GlaxoSmithKline drug dostarlimab (Jemperli) for endometrial cancer that carries a particular genetic signature. The immunotherapy now joins Merck's Keytruda as the checkpoint ...
FDA expands approval for GSK’s RSV vaccine to cover younger at-risk adults. By Helen Branswell June 7, 2024. ... Prior to this FDA decision, Arexvy was licensed for use in people 60 and older.
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