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As U.S. regulators approve more medicines under a so-called accelerated approval pathway, Medicare and Medicaid continue to spend more on treatments, even though the clinical benefits remain unproven, according to two new analyses.

Accelerated approval refers to early endorsements of medicines that treat serious conditions and fill an unmet medical need based on a surrogate marker that is “reasonably likely” to predict clinical benefits. From 1992 through 2020, the U.S. Food and Drug Administration issued more than 250 accelerated approvals, mostly cancer treatments.

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