Market Access News | pharmaphorum

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Seeking a lead over rival Mineralys, AstraZeneca is using a priority review voucher for its US filing for uncontrolled hypertension drug baxdrostat.

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Long-serving FDA figure Richard Pazdur has filed papers to retire, shortly after being appointed to lead CDER, according to reports.

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J&J's Imaavy has become the first FcRn blocker to be approved in the EU for both adolescent and adult patients with generalised myasthenia gravis.

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The FDA has revealed the latest element in its adoption of AI, an agentic AI platform that agency staffers can use to streamline complex tasks.

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A deal between the UK and the US will maintain tariffs on imports into the US at 0%, but prices of medicines used by the NHS will go up.

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The EMA has started a review of a regimen based on Pfizer/Astellas' Padcev and MSD's Keytruda that is described as a game-changer for bladder cancer.