Sage says it is ending dalzanemdor development in Huntingtons disease cognitive impairment following Phase 2 DIMENSION results that did not meet prima...
FDA warns New Delhi, India-based Unexo Lifesciences about CGMP and other violations in its production of finished drugs.
FDA warns the Colgate-Palmolive Toms of Maine unit about CGMP violations in its manufacturing of finished drugs.
Federal Register notice: FDA makes available a draft guidance entitled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Prod...
Federal Register notice: FDA determines that GlaxoSmithKlines Jesduvroq (daprodustat) tablets were not withdrawn due to safety or effectiveness reason...
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Three stakeholders raise concerns about an FDA draft guidance on considerations for generating clinical evidence from multiregional clinical developme...
