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.
CDER updates its CDER NextGen Portal to allow Right to Try annual summary submissions for CDER-regulated products.
FDA posts a final guidance entitled Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steato...
FDA encourages drug sponsors to use centralized statistical monitoring to help keep an eye on clinical trial integrity issues.
McKinsey & Co. agrees to pay $650 million to settle both criminal and civil investigations into its advisory work with Purdue Pharma and the marketing...
FDA clears a Zimmer Biomet 510(k) for the OsseoFit Stemless Shoulder System for total shoulder replacement.
