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 Agios mulls early FDA filing for sickle cell therapy Agios is planning to file its sickle cell disease candidate mitapivat with the FDA under the accelerated pathway within the next few months.
News Parexel buys Vitrana to boost patient safety toolkit Contract research organisation Parexel has bought Vitrana and its AI-powered pharmacovigilance platform for an undisclosed sum.
Digital Sponsored Discover a new era of healthcare panel engagement: Grounded ... A new webinar from Konovo will address some of the critical topics impacting today’s healthcare market research industry.
