Oncology Dose optimisation in oncology: Insights from AACR 2026 and i... Five years after its launch, the FDA’s Project Optimus remained a key theme in discussions at AACR 2026.
News Amgen, AZ will pilot FDA's real-time clinical trial plan The FDA has published a plan to allow data from clinical trials to be reported to the agency as they occur in real time.
News FDA grants three priority vouchers to psychedelics The FDA dropped a surprise Friday announcement that three more National Priority Vouchers would be given to a trio of psychedelics companies.
News Trump signs order to hasten psychedelic medicine access Donald Trump has signed an executive order directing the FDA to reduce regulatory hurdles that stand in the way of bringing psychedelics to patients.
News FDA accelerated approval path needs improvement, says ICER The FDA's accelerated approval route has delivered important new drugs to patients quicker, but is opaque and plagued by inconsistencies, says ICER.
News FDA renews criticism of trial sponsors over transparency The FDA has launched a drive to get clinical trial sponsors to disclose the results of studies – even if they are negative.
News Lundbeck preps for key bexicaserin data around year-end Lundbeck has completed patient randomisation in a pivotal trial of epilepsy candidate bexicaserin, one of its major growth hopes.
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