An FDA safety alert on certain diabetes devices that rely on a smartphone to deliver critical safety alerts warns that these may malfunction at times.
A Bloomberg Law report says New York is the latest state to indicate an interest in the FDA pathway to import lower-cost drugs from Canada.
Kura Oncology and Kyowa Kurin say they expect to submit a ziftomenib NDA to FDA in the second quarter of 2025.
FDA grants Acrivon Therapeutics a breakthrough device designation for the ACR-368 OncoSignature assay, a multiplex immunofluorescence assay for identi...
Baxter Healthcare Corporation recalls its Life2000 Ventilator System due to a nonconforming battery charger.
Novo Nordisk says a recent Phase 2 trial of monlunabant in diabetic kidney disease patients failed to meet its primary endpoint.
FDA warns Chinas Center for Instrumental Analysis of China Pharmaceutical University about CGMP deviations in its work as a contract testing facility ...
FDA says a Trokamed recall updating instructions for its Mini PCNL sheath was Class 1.
