News MSD claims two national priority vouchers; report The next two discretionary priority vouchers to be awarded by the FDA are reported to be heading for two MSD drug candidates.
News Antibiotic is first approval in FDA national priority scheme FDA approves its first 'national priority' drug – a version of the widely used antibiotic Augmentin XR – in double-quick time.
News FDA set to raise bar for clinical trials of CAR-T therapies The FDA could make it harder for developers of CAR-T therapies to bring them to market by requiring full randomised controlled trials.
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 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 Tracy Beth Hoeg will be fifth CDER head this year Tracy Beth Høeg, who has very little regulatory experience, is making the switch from CBER to replace FDA veteran Richard Pazdur.
News Lilly's 'triple G' retatrutide aces crucial obesity trial Lilly's retatrutide achieved weight loss of more than 30% at two years in a new trial, firming up its credentials as a next-generation obesity drug.
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