FDA raises efficacy questions about a Y-mAbs BLA for I-omburtamab to treat pediatric patients with CNS/leptomeningeal metastases from neuroblastoma.
The CDRH Digital Health Center of Excellence releases a document highlighting topics of interest for regulatory science research and partnerships.
GSK decides not to seek FDA approval for otilimab, an investigational monoclonal antibody targeting granulocyte-macrophage colony-stimulating factor a...
Federal Register notice: FDA sends to OMB an information collection extension entitled 510(k) Third-Party Review Program.
FDA posts eight generic drug research priority initiatives for FY 2023.
FDA says Baxter International has issued an urgent medical device correction for its WatchCare incontinence system that may cause radio interference w...
FDA publishes a guidance to help agency staff request additional information needed to make decisions on medical device marketing applications.
The Medical Device Innovation Consortium releases its first medical device manufacturer benchmark report on cybersecurity maturity.
