CDER explains how it used artificial intelligence/machine learning (AI/ML) to help identify the patient population most likely to benefit from Sobis K...
FDA grants Zymedi an orphan drug designation for ZMA001, a monoclonal antibody in development for pulmonary arterial hypertension.
FDA and Health Canada issue a notice alerting healthcare providers and facilities about the safe use of Megadyne Medical Products Mega 2000 and Mega S...
Researchers from FDA and other entities recommend ways to improve the collection and analysis of overall survival (OS) data in cancer drug trials.
Three stakeholders recommend changes to an FDA draft guidance on human- and animal-derived materials in cell and gene therapeutic materials.
FDA publishes an International Council on Harmonization guidance on bioequivalence studies for immediate-release solid oral dosage forms.
FDA clears a Life Spine 510(k) for its ARx SAI (sacral alar iliac) Spinal Fixation System.
Two Axinn attorneys say FDA may be signaling more flexibility in considering novel Section viii carve-in statements in ANDAs.
