News FDA reveals real-world pilot for digital health tools The FDA is rolling out a pilot programme that could make it easier to bring digital health technologies for chronic diseases to market more quickly.
News CDC panel votes to scrap hepatitis B birth dose advice CDC advisers vote to overturn decades of US policy and abandon endorsement of universal hepatitis B vaccination for newborns in the US.
News FDA could hike user fees for ex-US drug programmes FDA mulls reduced fees for programmes with US-based phase 1 trials, and higher fees for those tested overseas, to incentivise US R&D.
News FDA takes steps to limit non-human primate testing New draft guidance from the FDA says single-target antibodies will no longer need six-month toxicity testing in animals like macaques.
News FDA doubles down on its push into AI 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.
News UK and US agree zero tariffs on pharma – with price rises 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.
News Lilly bags FDA okay for Wegovy pill rival orforglipron Eli Lilly has claimed US approval for oral GLP-1 agonist orforglipron, setting up a market clash with Novo Nordisk's first-to-market Wegovy pill.
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