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Federal Register notice: FDA released a final guidance on Chemistry, Manufacturing, and Control information for gene therapy INDs.[ Price : $8.95]
Federal Register notice: FDA posts a final guidance on human gene therapy development for hemophilia.[ Price : $8.95]
Public Citizen sues FDA in DC federal court to obtain the scientific reviews used to grant accelerated approval for Janssen Pharma...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Interpreting Sameness of Gene Therapy Products Under the Or...[ Price : $8.95]
Federal Register notice: FDA posts a final guidance on human gene therapy for retinal disorders.[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance on rare disease gene therapy development.[ Price : $8.95]
Three stakeholders voice support for an FDA novel excipient review program.[ Price : $8.95]
FDA grants a priority review to an Eli Lilly NDA for selpercatinib and its use for treating patients with advanced RET fusion-posi...