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 ...
FDA says two AAMI standards are recognized consensus standards.
FDA clears a BioIntelliSense 510(k) for the BioSticker on-body sensor for remote monitoring and care.
Johnson & Johnson says its Janssen unit is cooperating with regulators, healthcare organizations, and others in a multi-pronged effort to respond to t...
FDA issues a guidance to help applicants develop labeling information demonstrating the connection between antihypertensive drugs and improved cardiov...
Stakeholders generally support the FDA position on clinical immunogenicity studies for biosimilar and interchangeable insulin products.