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.
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News AZ uses a priority review voucher for baxdrostat filing Seeking a lead over rival Mineralys, AstraZeneca is using a priority review voucher for its US filing for uncontrolled hypertension drug baxdrostat.
News FDA takes steps to limit non-human primate testing New draft guidance from the FDA says single-target antibodies will no longer need six-month toxicity testing in animals like macaques.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 Europe is facing a surge in STIs, says ECDC Cases of sexually-transmitted infections (STIs) – particularly gonorrhoea and syphilis – are at record levels across 29 European countries.
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