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 Imperial Palace Commodity about CGMP violations in its manufacturing of over-the-counter drugs.
FDA warns Pompano Beach, FL-based BioStem Life Sciences that it is illegally marketing cellular products that also reflect CGMP violations.
FDA warns Indias Global Calcium about CGMP deviations in its manufacture of active pharmaceutical ingredients.
