Federal Register notice: FDA released a final guidance on Chemistry, Manufacturing, and Control information for gene therapy INDs.
Federal Register notice: FDA posts a final guidance on human gene therapy development for hemophilia.
Public Citizen sues FDA in DC federal court to obtain the scientific reviews used to grant accelerated approval for Janssen Pharmaceuticals bladder ca...
Federal Register notice: FDA makes available a draft guidance entitled Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulation...
Federal Register notice: FDA posts a final guidance on human gene therapy for retinal disorders.
Federal Register notice: FDA makes available a final guidance on rare disease gene therapy development.
Three stakeholders voice support for an FDA novel excipient review program.
FDA grants a priority review to an Eli Lilly NDA for selpercatinib and its use for treating patients with advanced RET fusion-positive non-small cell ...