AMAG Pharmaceuticals files a supplemental NDA for Makena (hydroxyprogesterone caproate injection) to allow a subcutaneous auto-injector to deliver the...
FDA denies a CytoDyn request for an orphan drug designation for PRO 140 because the therapy appears to have the potential to treat more than just the ...
Editor Jim Dickinson analyzes a remarkable case of apparent and highly questionable FDA collusion with a medical device companys marketing campaign ag...
FDA schedules a 5/24 Oncologic Drugs Advisory Committee meeting to review a Puma Biotechnology NDA for neratinib, an investigational therapy for the e...
FDA releases a Form-483 from a 2/7-17 inspection at Abbotts St. Jude Medical manufacturing facility in Sylmar, CA, that found Quality System Regulatio...
Federal Register notice: FDA announces a 5/8-9 Pharmacy Compounding Advisory Committee meeting that will hearing compounding updates and discuss addin...
OncoMed Pharmaceuticals says results from a Phase 2 trial evaluating tarextumab failed to meet its primary endpoint (progression free survival) or sec...
FDA approves Genentechs Lucentis (ranibizumab injection) 0.3 mg for the monthly treatment of all forms of diabetic retinopathy.