FDA adds a liver injury Boxed Warning to labeling for Astellas menopause hot flash drug Veozah.
Lexicon stops development of its diabetes drug Zynquista that received an FDA complete response letter.
CDER senior advisor for clinical science Bob Temple retires, and FDA principal deputy commissioner Namandj Bumpus leaves the agency ahead of the new i...
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 warns Albuquerque, NM-based Sombra Cosmetics about CGMP violations in the manufacturing of finished drugs.
FDA approves Mesoblasts Ryoncil to treat some graft-versus-host disease pediatric patients.
