News FDA takes steps to limit non-human primate testing New draft guidance from the FDA says single-target antibodies will no longer need six-month toxicity testing in animals like macaques.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 Pazdur to leave FDA, shortly after taking CDER job Long-serving FDA figure Richard Pazdur has filed papers to retire, shortly after being appointed to lead CDER, according to reports.
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 Slow recruitment still hitting UK trials, says pharma Despite efforts to improve the environment for UK clinical trials, the sector is still facing headwinds like low recruitment rates and rising costs.
News EMA starts review of 'transformative' bladder cancer therapy 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.
News Belite plans filing for oral Stargardt drug after phase 3 wi... The first therapy for sight-robbing Stargardt disease could be on the way, as Belite Bio's tinlarebant hits the mark in a phase 3 trial.
News UK offers meningitis jab to young people after outbreak The UK government has responded to calls to broaden vaccinations for meningitis B, offering the jab to "thousands" of young people this summer.
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