News CDC signs off on advice ending universal hepatitis B jabs Overturning decades of advice, the CDC has said it no longer recommends that all US newborns receive a hepatitis B vaccine.
News J&J claims FDA's latest national priority voucher The FDA has awarded its latest national priority voucher to Johnson & Johnson for a combination regimen based on Tecvayli for multiple myeloma.
News Are RSV shots next in line for restrictions in the US? After pushing for restrictions on vaccines for COVID-19 and hepatitis B, the Trump administration seems to be turning its attention to RSV shots.
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 backs first AI tool for use in trials, targeting MASH The FDA has qualified the first AI-based tool that can be used in clinical trials involving patients with MASH to help measure disease activity.
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