The FDA Office of Inspections and Investigations ombudsman program calls for establishing a dedicated Web page as a stakeholder education hub.
FDA approves an Orchestra BioMed IDE to begin a pivotal clinical trial evaluating its next generation Virtue Sirolimus-AngioInfusion Balloon for treat...
FDA grants Italfarmaco a fast track designation to givinostat for treating patients with polycythemia vera, a rare hematologic cancer.
FDA commissioner Michael Makary says the agency is rolling out a generative AI-assisted scientific review tool to all Centers by 6/30.
A northern Texas judge rules in FDAs favor in a case challenging its decision last year to remove Eli Lillys weight loss and diabetes drugs Zepbound a...
SS Innovations says it will seek a de novo marketing authorization in July for its SSi Mantra 3 surgical robotic system.
Former CDER Office of Compliance director Don Ashley says inspection disruptions caused by recent FDA reductions in force will not rise to the level o...
Theriva Biologics reports positive Phase 2b VIRAGE topline results for its VCN-01 when added to standard of care chemotherapy to treat a form of pancr...