FDA asks members of its Digital Health Advisory Committee to spend two days discussing agency questions about its role in regulating generative artifi...
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Three stakeholders raise concerns about an FDA draft guidance on considerations for generating clinical evidence from multiregional clinical developme...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FDA posts a draft guidance entitled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products.
FDA accepts for review an Aldeyra Therapeutics NDA for reproxalap, an investigational topical new drug candidate for treating signs and symptoms of dr...
