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 gives Sellas Life Sciences Group a Rare Pediatric Disease Designation for SLS009, a highly selective CDK9 inhibitor for treating pediatric acute m...
Federal Register notice: FDA announces that Argenxs supplemental NDA for Vyvgart Hytrulo for treating chronic inflammatory demyelinating polyneuropath...
