Precision BioScience says it will meet with FDA in June to discuss a regulatory way forward through a Phase 2 trial for its azer-cel in patients with ...
Sixteen advocacy organizations urge FDA to regulate laboratory-developed tests if Congress fails to produce a strong bill.
FDA completes a previously delayed pre-licensing inspection of China-based Shanghai Junshi Biosciences breakthrough cancer drug toripalimab manufactur...
FDA and the European Union agree to expand the scope of the U.S.-EU mutual recognition agreement to include inspections of veterinary pharmaceuticals.
FDA says that beginning 6/12 it will expand in-person industry meetings to include requests for Type B End-of-Phase 2 requests at CDER/CBER.
CDRH announces a 9/6 Patient Engagement Advisory Committee meeting to discuss and make recommendations on Advancing Health Equity in Medical Devices....
Sanofi says data from a Phase 2 trial of frexalimab significantly reduced disease activity in patients with relapsing multiple sclerosis.
FDA alerts patients and healthcare providers to concerns about compounded semaglutide that is being produced as an alternative to approved versions Oz...
