FDA sends an untitled letter to Sanofi Vaccines U.S., alleging that promotional emails for its respiratory syncytial virus prevention product Beyfortus (nirsevimab-alip) were false or misleading because they overstated the drug's approved indication.
Novo Nordisk sues Lilly in New Jersey federal court over what the company says is a misleading national ad campaign that compares the two companies’ GLP-1 drugs and purports to demonstrate the superiority of Lilly’s tirzepatide over semaglutide.
FDA sends an untitled letter to Sanofi Vaccines U.S., alleging that promotional emails for its respiratory syncytial virus prevention product Beyfortus (nirsevimab-alip) were false or misleading because they overstated the drug's approved indication.
Novo Nordisk sues Lilly in New Jersey federal court over what the company says is a misleading national ad campaign that compares the two companies’ GLP-1 drugs and purports to demonstrate the superiority of Lilly’s tirzepatide over semaglutide.
In a mid-year enforcement update, Arnold Golden Gregory partner Gabriel Scannapieco says FDA and the Department of Justice are increasingly extending enforcement actions beyond traditional drug manufacturers.
A 7/20 opinion article contends that FDA acting commissioner Kyle Diamantas has outlined a broad vision for modernizing FDA by emphasizing innovation, artificial intelligence, advanced manufacturing, and supply chain resilience.
