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...
Theriva Biologics reports positive Phase 2b VIRAGE topline results for its VCN-01 when added to standard of care chemotherapy to treat a form of pancr...
A Moderna Phase 3 study says its combination mRNA flu and Covid-19 vaccine achieved a greater immune response than comparator standard of care vaccine...
FDA accepts for review an Omeros BLA resubmission for narsoplimab for treating hematopoietic stem cell transplant-associated thrombotic microangiopath...
