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The FDA has set PDUFA dates for several products: Arexvy to prevent RSV in 50 to the 59 population, for acoramidis in heart failure indication, and for an engineered tissue for vascular replacement. The agency has also scheduled an advisory committee meeting for Abecma in supplemental multiple myeloma indication. Additionally, Amneal has resubmitted its application for novel Parkinson’s therapy.

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Republicans voted in favor of a bill that would prohibit the use quality-adjusted life years (QALY) metrics by federal agencies, Medicare Advantage plans and Medicaid managed care organizations. Some patient groups celebrated the passage. Experts have worried that "similar measures" language could stifle all comparative effectiveness analysis.

Should site-neutral payment rules and policies be extended to commercial payers, payment for physician-administered drugs, and services delivered in on-campus hospital outpatient departments?