FDA medical reviewer raise some issues about Lillys investigational Alzheimers drug donanemab for advisory committee members to consider.
The Government Accountability Office says stakeholder groups have identified issues with OTC hearing aids that need to be monitored.
Reps. DeGette and Buchson ask for input on steps Congress can take to help develop the next generation of healthcare treatments.
FDA and the Clinical Trials Transformation Initiative announce an 8/6 hybrid public workshop on artificial intelligence in drug and biological product...
University of MissouriKansas City researchers say pediatric orthopedic device innovation lags substantially behind adult device innovation.
FDA clears a Diasorin 510(k) for its Liaison Plex Yeast Blood Culture Assay for microbiological diagnosis of bloodstream infections.
FDA places a clinical hold on Biomea Fusions Phase 1-2 clinical trials of its investigational covalent menin inhibitor BMF-219 in Type 2 and Type 1 di...
FDA denies a Nautilus Gloves request that the agency not rescind its 510(k) clearance for nitrile exam gloves and instead allow the company to substit...
