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The WHO has recommended Gilead's twice-yearly HIV PrEP drug lenacapavir, calling it 'transformational', but there are concerns about patient access.

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Vertex has won NICE's backing for a new cystic fibrosis therapy, Alyftrek, that could be an option for 89% of NHS patients with the genetic disorder.

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A UK consortium has been set up to tackle a major issue in the development of cell and gene therapies (CGT) – a lack of manufacturing capacity.

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Bayer's Kerendia has won FDA approval for a new heart failure indication thought to be pivotal for the product's blockbuster sales prospects.

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Bayer has its first regulatory approval for non-hormonal menopause treatment elinzanetant – in the UK – as it chases down a rival drug from Astellas.

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The FDA says publishing complete response letters for medicines is an act of "radical transparency," but it is not as revolutionary as it seems.