News FDA blocks trials that send US cells to 'hostile' countries The FDA says it will review clinical trials that send US citizens' cells to 'hostile countries' as the agency's leadership in this area is sidelined.
News FDA unveils fast-track review path for 'national priorities' FDA Commissioner Marty Makary has revealed a new priority review voucher programme for new medicines deemed to be of national priority for the US.
Market Access BIO 2025: Makary: Drugs don’t have to take 10 years to get t... FDA Commissioner Dr Martin Makary took the stage at BIO 2025 to detail the way he and his team have been challenging “deeply held assumptions”.
News Makary, Prasad set out their vision for the FDA Top FDA officials have spelled out their strategic priorities in the coming years, including the use of AI to "increase efficiency."
News Amid staff cuts, FDA looks to AI to 'optimise' reviews The FDA has rolled out its highly-touted generative AI tool, almost a month early, with a promise to reduce the time taken for regulatory reviews.
News Lilly bags FDA okay for Wegovy pill rival orforglipron Eli Lilly has claimed US approval for oral GLP-1 agonist orforglipron, setting up a market clash with Novo Nordisk's first-to-market Wegovy pill.
Sales & Marketing Sponsored Using AI-driven synthetic personas to take your insights fur... As AI continues to reshape the healthcare landscape, pharma teams are beginning to leverage synthetic personas.
