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Lexicon stops development of its diabetes drug Zynquista that received an FDA complete response letter.[ Price : $8.95]
CDER senior advisor for clinical science Bob Temple retires, and FDA principal deputy commissioner Namandj Bumpus leaves the agenc...[ Price : $8.95]
Xbrane Biopharma refiles a BLA for its investigational ranibizumab, a biosimilar copy of Genentechs age-related macular degenerati...[ Price : $8.95]
FDA issues a safety alert on Nuwellis AquaFlexFlow UF 500 Plus extracorporeal blood circuit because the device may trigger a weigh...[ Price : $8.95]
Four senators introduce bipartisan legislation to protect generic drug manufacturers from innovator drug lawsuits over skinny labe...[ Price : $8.95]
FDA publishes an International Council for Harmonization draft M15 guidance on model-informed drug development principles.[ Price : $8.95]
FDA publishes a guidance with recommendations for participating in the agencys Advanced Manufacturing Technologies Designation Pro...[ Price : $8.95]
FDA publishes the International Council on Harmonization E11A Pediatric Extrapolation guidance.