Sesen Bio begins a rolling BLA for vicinium for treating BCG-unresponsive non-muscle invasive bladder cancer.
Federal Register notice: FDA makes available a draft guidance entitled Development of Locally Applied Corticosteroid Products for the Short-Term Treat...
FDA clears a LimaCorporate and TechMah Medical 510(k) for the Smart Space Shoulder 3D Planner & 3D Positioner for shoulder arthroplasty.
Genus Medical Technologies wins a court decision against FDA to have its contrast agent Vanilla SilQ products regulated as devices as opposed to drugs...
FDA says that ongoing concerns about the presence of genotoxic impurities (nitrosamines) in angiotensin II receptor blockers and ranitidine have now s...
Federal Register notice: FDA releases a draft guidance on Magnetic Resonance (MR) Coil Performance Criteria for Safety and Performance Based Pathway....
Republican House lawmakers introduce the Lower Costs, More Cures Act (H.R. 19) to lower drug costs for Americans without limiting access to cures.
FDA grants Equillium a fast track designation for itolizumab for treating lupus nephritis.