FDA clears a Nesa Medtech 510(k) for its Fibroid Mapping Reviewer Application (FMRA), intended for use by physicians to generate a 3D model of the ute...
FDA approves a Verrica Pharmaceuticals NDA for Ycanth (cantharidin) topical solution for treating molluscum contagiosum (molluscum) in adult and pedia...
Datascope recalls its Cardiosave Rescue IntraAortic Balloon Pumps because of the potential for an unexpected shutdown of the pump.
ADC Therapeutics says it is discontinuing its Phase 2 LOTIS-9 clinical trial evaluating Zynlonta (loncastuximab tesirine-lpyl) and rituximab in certai...
Federal Register notice: FDA withdraws approval of an NDA for Bufferin (aspirin) tablets because the application holder has failed to file required an...
FDA approves an Emergent BioSolutions BLA for Cyfendus (anthrax vaccine adsorbed, adjuvanted) for anthrax post-exposure prophylaxis.
Former medical device regulatory affairs specialist Peter Stoll pleads guilty on one felony count for distributing medical devices without FDA clearan...
CDER Counterterrorism and Emergency Coordination Staff director Rosemary Roberts announces her retirement this month.
