The Government Accountability Office says laboratory testing of three dietary supplements marketed to improve memory did not contain ingredients and q...
FDA approves Stallergenes Greers Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass mixed pollens allergen extract) for t...
FDA clears a Canon Medical Systems 510(k) for its new premium MRI system, Vantage Orian 1.5T.
FDA accepts for priority review a Genentech supplemental BLA for Tecentriq (atezolizumab) plus chemotherapy for first-line treatment of unresectable l...
FDA approves a PolyPid Ltd. IND for it to proceed with a Phase 3 clinical trial involving lead candidate D-Plex[100] for preventing post-cardiac surge...
Federal Register notice: FDA seeks comments on an information collection extension on a guidance for Medical Device User Fee Small Business Qualificat...
A Tufts Center for the Study of Drug Development analysis says the global biotech product development surge that started in the 1980s continues to gro...
FDA issues a draft guidance on considerations for using a metastasis-free survival endpoint in some prostate cancer drug trials.