FDA posts an International Council for Harmonization-developed guidance entitled M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities ...
The Biden Administration threatens to veto a House spending measure that includes cuts to FDAs budget.
Syndax Pharmaceuticals and Incyte plan to file by the end of the year a BLA for axatilimab, for use in adult and pediatric patients with chronic graft...
Horizon Therapeutics says a Phase 2 clinical trial evaluating daxdilimab for treating systemic lupus erythematosus failed to meet its primary endpoint...
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...
