Two FDA advisory committees vote in a joint meeting to recommend approval of Mallinckrodt subsidiary SpecGxs investigative abuse-deterrent formulation...
PharmaCyte Biotech completes an FDA-required formal report on safety studies using a pig model that were undertaken before getting the agency to sign ...
FDA releases an FDA-483 with eight observations from a recent inspection at a Dr. Reddys manufacturing facility in India.
Federal Register notice: FDA announces a 2/4 public workshop entitled Evaluating the Pressor Effects of Drugs.
Federal Register notice: FDA makes available a draft guidance entitled Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metasta...
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.