Federal Register notice: FDA classifies the spore test strip into medical device Class 2 (special controls).
Federal Register notice: FDA classifies the adjunctive predictive cardiovascular indicator into medical device Class 2 (special controls).
FDA approves a Senseonics Holdings next-generation Eversense E3 continuous glucose monitoring system and its use for up to six months.
Y-mAbs Therapeutics plans to re-submit a BLA on omburtamab for treating patients with CNS/leptomeningeal metastases from neuroblastoma after getting p...
Pfizer and BioNTech delay their rolling BLA for an amended Emergency Use Authorization for the Covid-19 vaccine to include young children because data...
FDA clears an Esaote North America 510(k) for its Magnifico Open MRI, a whole-body MRI system.
FDA grants Eli Lilly an emergency use authorization for its monoclonal antibody bebtelovimab and its use in treating Covid-19, including the omicron v...
Taiho Oncology asks FDA to not allow applicants for generic Lonsurf to carve out labeling information from a dedicated Taiho renal study that was a po...