Pink SheetA warning letter the US Food and Drug Administration issued 10 August shows that the Bayview plant in Baltimore was not the only Emergent BioSolutions, Inc. facility to falter on quality during the
Pink SheetMonoclonal antibodies in development to prevent respiratory syncytial virus (RSV) in children will not only have to satisfy US Food and Drug Administration requirements for product licensure, they wil
Pink SheetThe US Food and Drug Administration’s efforts to build a framework for speeding responses to emerging infectious diseases and biowarfare threats – collectively known as medical countermeasures – have
Pink SheetNovel approvals from FDA's Center for Biologics Evaluation and Research grew for a fourth consecutive year in 2015, sending off retiring center director Karen Midthun with a record high count of 12 ne