Celgene discontinues its Phase 3 REVOLVE trial (CD-002) in Crohns disease and the extension trial (SUSTAIN, CD-004) that are both studying GED-0301 (m...
Federal Register notice: FDA makes available a draft guidance for industry on generic tiotropium bromide inhalation powder.
Federal Register notice: FDA makes available three draft guidances for industry on generic salmeterol xinafoate inhalation powder, fluticasone propion...
FDA posts an internal policy and procedures document entitled CMC Reviews of Type III DMFs for Packaging Materials.
FDA issues an FDA-483 detailing 11 observations from an inspection at the Atlas Pharmaceuticals outsourcing facility.
FDAs Endocrinologic and Metabolic Drugs Advisory Committee votes 16-0 to recommend approval of Novo Nordisks once-weekly semaglutide to improve glycem...
Attorney Ritte van Laack says a New York federal court dismissed an FTC suit alleging that Quincy Bioscience made unsubstantiated advertising claims f...
FDA approves Nexus Pharmaceuticals procainamide HCl injection as a multi dose vial containing 1,000 mg per 2 mL or as a multi dose vial containing 1,0...