FDA clears a Hyperfine 510(k) for the ninth generation of artificial intelligence-powered Swoop magnetic resonance software.
Bayer says it will present positive results from a Phase 3 Nubeqa prostate cancer trial to FDA to consider a potential indication expansion for the dr...
FDA accepts for priority review an Atara Biotherapeutics BLA for gene therapy tabelecleucel, indicated as monotherapy for treating Epstein-Barr virus-...
The FDA FY 2023 drug and medical device establishment inspection report lists registered establishments and inspections by type and world region.
FDA says a 4/1 Philips Respironics recall revising the use instructions for its OmniLab Advanced+ ventilator is Class 1.
FDA clears a Subtle Medical 510(k) for its SubtleSYNTH, which uses deep learning to generate synthetic Short Tau Inversion Recovery images from alread...
FDA warns Chinas YangZhou SuXiang Medical Instrument Co. about CGMP violations in its manufacturing of finished drugs.
FDA warns Chinas Jiangsu Hengrui Pharmaceuticals about CGMP violations in its manufacturing of finished drugs
