Xbrane Biopharma refiles a BLA for its investigational ranibizumab, a biosimilar copy of Genentechs age-related macular degeneration drug Lucentis.
FDA issues a safety alert on Nuwellis AquaFlexFlow UF 500 Plus extracorporeal blood circuit because the device may trigger a weight mismatch alarm whi...
Four senators introduce bipartisan legislation to protect generic drug manufacturers from innovator drug lawsuits over skinny labeled generics.
FDA publishes an International Council for Harmonization draft M15 guidance on model-informed drug development principles.
FDA publishes a guidance with recommendations for participating in the agencys Advanced Manufacturing Technologies Designation Program.
FDA publishes the International Council on Harmonization E11A Pediatric Extrapolation guidance.
FDA publishes Annex 2 of the International Council on Harmonization Good Clinical Practice guidance.
FDA warns Albuquerque, NM-based Sombra Cosmetics about CGMP violations in the manufacturing of finished drugs.
