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As part of the 0% tariff deal, the NHS will pay 25% more for innovative medicines.
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While the WHO is still assessing the scale of the impact of foreign aid cuts, access to PrEP medication is believed to have dropped dramatically.
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If approved, TSRA-196 could become the first curative therapy to reach patients with AATD.
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The NDA submission is based on findings from three randomised, double-masked, controlled Phase III studies carried out in the US.
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The designation enables sponsors to receive a paediatric priority review voucher.
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With $1.5 billion in drug sales, the US dominated the CKD-HPT, HP and HK market in 2024, representing 59.7% of 7MM sales.
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