Sept. 20, 2021 – Six out of 18 cancer drugs that initially received accelerated approval from the FDA have indications that remain on the labeling and continue to be recommended in clinical guidelines despite post-approval trials demonstrating no improvement in the primary endpoint, according to a retrospective observational study published Sept. 9 by BMJ. “The […]
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May 6, 2021 – The outcome of a recent Advisory Committee meeting convened to review the uses of certain cancer drugs that were approved under the Food and Drug Administration’s (FDA’s) accelerated approval process sheds light on the potential pitfalls of the process after the approvals are granted. The FDA Oncologic Drugs Advisory Committee voted […]
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