USpolicy

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Regeneron's Otarmeni is the first gene therapy for congenital hearing loss to be cleared by the FDA, and will be made available for free in the US.

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Medicare will cover the cost of a pilot of weight-loss drug coverage, after health insurers refuse to take part.

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Donald Trump has signed an executive order directing the FDA to reduce regulatory hurdles that stand in the way of bringing psychedelics to patients.

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Former Deputy Surgeon General Erica Schwartz could end months at the CDC without Senate-confirmed leadership if she becomes Director.

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The FDA's accelerated approval route has delivered important new drugs to patients quicker, but is opaque and plagued by inconsistencies, says ICER.

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The FDA has launched a drive to get clinical trial sponsors to disclose the results of studies – even if they are negative.