FDA approves Johnson & Johnsons Opsynvi, a combination single tablet of macitentan and tadalafil for treating adults with pulmonary arterial hypertens...
FDA sends Regeneron Pharmaceuticals two complete response letters on its BLA for odronextamab in relapsed/refractory follicular lymphoma and in R/R di...
Following recent Congressional action giving FDA additional authorities, the agency is again proposing a rule to ban electrical stimulation devices in...
A new Government Accountability Office report says FDA needs to evaluate its recruitment and retention efforts to support and maintain its investigato...
Federal Register notice: FDA announces a 4/12 Oncologic Drugs Advisory Committee meeting to discuss the use of minimal residual disease as an endpoint...
CDER creates a new Center of Excellence for Quantitative Medicine to advance therapeutic medical product development and inform regulatory decision-ma...
FDA posts a notification about four information collections that have been approved by OMB.
Teleflex/Arrow International recalls the Arrow QuickFlash Radial Artery Catheterization Set (wire, guide, catheter) device due to reports about a pote...
