Chimerix files an NDA seeking accelerated approval for dordaviprone as a treatment for patients with recurrent H3 K27M-mutant diffuse glioma.
Federal Register notice: FDA announces a 5/15 public meeting entitled Implementation of the Best Pharmaceuticals for Children Act and Pediatric Resear...
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 issues a complete response letter for Zealands glepaglutide intended to treat short bowel syndrome.
FDA warns a Viatris Mylan drug manufacturing facility in Pradesh, India, about CGMP violations involving quality and data issues.
