SS Innovations says it will seek a de novo marketing authorization in July for its SSi Mantra 3 surgical robotic system.
FDA again misses a user fee review action decision in the wake of mass staff cuts, the third miss in a month this time it's a GSK Nucala sNDA for tre...
Speakers at the DTC National conference suggest a ban on drug DTC ads is not very likely.
Former FDA commissioners Scott Gottlieb and Mark McClellan voice concerns about an HHS proposed reorganization of FDA that would centralize the review...
CBS News reports that FDA associate commissioner for inspections and investigations Michael Rogers is retiring, frustrated over changes being made by ...
FDA taps former Booz Allen Hamilton chief technologist Jeremy Walsh to lead its artificial intelligence (AI) and information technology efforts in a n...
FDA approves Teva Pharmaceuticals and Alvotechs Selarsdi injection as an interchangeable biosimilar to Janssens reference biologic Stelara (ustekinuma...
Former CDER Office of Compliance director Don Ashley says inspection disruptions caused by recent FDA reductions in force will not rise to the level o...