FDA sends Astellas Pharma a complete response letter on a supplemental NDA for Izervay (avacincaptad pegol intravitreal solution) seeking revised drug...
Three stakeholders raise concerns about an FDA draft guidance on considerations for generating clinical evidence from multiregional clinical developme...
Merck reports positive topline results from a trial that evaluated the noninferiority of subcutaneous administration of Keytruda (pembrolizumab) versu...
FDA seeks input 11/21 from its Cellular, Tissue, and Gene Therapies Advisory Committee about AstraZenecas Andexxa and an increased risk of thrombosis ...
GSK says its Phase 3 GLISTEN trial evaluating linerixibat in adults with a relentless itch associated with primary biliary cholangitis met its primary...
FDA warns New Delhi, India-based Unexo Lifesciences about CGMP and other violations in its production of finished drugs.
FDA warns Italys Originitalia about CGMP violations in its production of finished drugs.
Novo Nordisk petitions FDA to take specific steps to follow through on the companys nomination of semaglutide (Rybelsus, Ozempic, Wegovy) to the lists...
