FDA accepts for priority review a Telix NDA for Pixclara (18F-floretyrosine), a positron emission tomography agent for glioma imaging.
FDA says the CDER Office of Prescription Drug Promotion will research how consumers and primary care physicians respond to drug ads containing informa...
FDA commissioner Robert Califf says the agency is being forced by artificial intelligence to rethink how it conducts business.
Alto Neuroscience says a study of its major depressive disorder investigational drug did not meet its primary endpoint.
Federal Register notice: FDA announces a 12/12 Vaccines and Related Biological Products Advisory Committee meeting to discuss considerations for pedia...
FDA warns Phoenix, AZ-based Pinnacle Transplant Technologies that it is illegally manufacturing and marketing amniotic products that have CGMP deviati...
Novo Nordisk asks FDA to add its semaglutide products to the lists of drugs that should not be compounded.
FDA approves an expanded indication for Pfizers Abrysvo RSV vaccine to include adults from age 18 and up.
