News FDA takes steps to limit non-human primate testing New draft guidance from the FDA says single-target antibodies will no longer need six-month toxicity testing in animals like macaques.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 Is FDA about to restrict vaccination even further? Vinay Prasad, head of CBER, is reported to be planning to tighten regulations on vaccines after concluding that COVID-19 shots caused 10 child deaths.
R&D Working together to innovate on pragmatic clinical trials, w... In today’s episode, host Jonah Comstock speaks with Rob DiCicco, vice president of portfolio management at TransCelerate Biopharma.
News FDA unveils swift route to market for personalised drugs FDA reveals a regulatory pathway for personalised therapies based on 'plausible mechanism', drawing on the bespoke gene-editing treatment of Baby KJ.
News Lilly's 'triple G' retatrutide aces crucial obesity trial Lilly's retatrutide achieved weight loss of more than 30% at two years in a new trial, firming up its credentials as a next-generation obesity drug.
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.
