FDA issues a CDER MAPP on converting approved ANDAs to temporary approval after receiving a court decision on patent infringement.
FDA grants CNS Pharmaceuticals an orphan drug designation for its lead product berubicin for treating malignant gliomas.
FDA approves Bristol-Myers Squibbs Opdivo for esophageal squamous cell cancer.
FDA warns the owner of OutoftheBoxRemedies.com that it and other Web sites are selling unapproved and misbranded iodine products to treat Covid-19.
FDA approves Pfizers Nyvepria, a biosimilar to Amgens Neulasta.
Federal Register notice: FDA seeks comments on an information collection revision for Medical Device User Fee Cover Sheet, Form FDA 3601and Device Fac...
FDA and FTC say the Web site organic-beauty-recipes.com is promoting essential oils that claim to prevent, treat, or cure Covid-19 as an Amazon Associ...
FDA approves a Curis IND application for CI-8993, which it describes as the first-in-class monoclonal anti-Vista antibody, for a Phase 1a/1b study of ...