FDA approves a UroGen Pharma NDA for Zusduri (mitomycin intravesical solution) for adult patients with recurrent low-grade intermediate-risk non-muscl...
FDA clears a Viz.ai 510(k) for the Viz Subdural Plus, which the company describes as the first and only comprehensive solution for quantifying the siz...
Rutgers University researchers say they have determined that the GlaxoSmithKline anti-seizure drug Lamictal is safe for adults with epilepsy and conco...
Saying that operational consolidations are coming in support services, FDA commissioner Martin Makary asks the staff to view change with openness and ...
FDA grants Sumitomo Pharma America a fast track designation for nuvisertib (TP-3654) and its use in treating patients with intermediate or high-risk m...
Current and former CDC employees rally outside the agencys Atlanta headquarters yesterday over Trump Administration-inspired chaos affecting the healt...
FDA warns Worland, WY-based Amish Origins Management about CGMP violations in its manufacturing of unapproved and misbranded drug products.
FDA publishes statistics on real-world evidence submissions to CBER and CDER in FY 2024 compared to the previous year.