CBER begins a phased implementation of in-person industry meetings with device manufacturers.
The Biotechnology Innovation Organization says it supports FDA efforts to promote stakeholder discussion on the role of artificial intelligence and ma...
Novo Nordisk says its Wegovy cut the risk of major adverse cardiovascular events by 20% in overweight or obese adults in the SELECT trial.
FDA approves a Boston Scientific PMA for the POLARx Cryoablation System for treating patients with paroxysmal atrial fibrillation.
FDA publishes a draft guidance on incorporating QTc prolongation-related information in drug and biological product labeling.
Federal Register notice: FDA determines that Cubist Pharmaceuticals Cubicin and Cubicin RF (daptomycin) powder for injection were not withdrawn due to...
Federal Register notice: FDA seeks comments concerning abuse potential and the impact of scheduling changes on availability for medical use of eight d...
Federal Register notice: FDA makes available a final guidance entitled Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Imp...
