Tag: clinical guidelines

clinical guidelines

Regulatory/FDA

BMJ Study: Accelerated Approval Drugs Retain Status Despite Lack of Benefit

BMJ Study: Accelerated Approval Drugs Retain Status Despite Lack of Benefit

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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