The 46 medicines given approval through 2017 as part of the FDA's Breakthrough Therapy program have often been sent to patients without a large double-blind study, direct measurement of benefit, or comparison with a placebo or existing treatment. READ MORE

News

The 46 medicines given approval through 2017 as part of the FDA's Breakthrough Therapy program have often been sent to patients without a large double-blind study, direct measurement of benefit, or comparison with a placebo or existing treatment.

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The US Food and Drug Administration has approved a 4-week dosing schedule for a commonly used cancer therapy.

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The US Food and Drug Administration has granted approval to a therapy in combination with an aromatase inhibitor for the treatment of a specific type of advanced breast cancer.

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The FDA has approved the first treatment for a type of localized prostate cancer, using a novel endpoint to support the approval.

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Interview

Jonathan J Darrow, SJD, JD, MBA, Harvard University, discusses his recent study that found that breakthrough drug designation may not offer the “breakthrough” benefits that this terminology suggests, leading to false hope and higher prices for patients.

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