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Gilead's twice-yearly HIV PrEP set for wider rollout
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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New cystic fibrosis triple from Vertex backed for NHS use
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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Bayer gets sought-after heart failure use for Kerendia
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 bags first world approval for hot flush therapy
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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Just how radical is the FDA's complete response letter move?
The FDA says publishing complete response letters for medicines is an act of "radical transparency," but it is not as revolutionary as it seems.
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