FDA approves Bio Products Laboratorys Gammaplex 10% (immune globulin intravenous [human], 10% liquid) for treating primary immunodeficiency and chroni...
Sanofi says that GMP inspection deficiencies are corrected and it will resubmit a joint BLA submission with Regeneron Pharmaceuticals for sarilumab, a...
FDA lifts a partial clinical hold on a Northwest Biotherapeutics Phase 3 trial of its personalized immune therapy DCVax-L for glioblastoma multiforme ...
Attorneys note that FDAs recent rule on intended use is a win for industry, but it is still under consideration for withdrawal as part of the Trump Ad...
FDA warns Koreas Neo Vision about Quality System problems in its manufacturing of soft daily wear contact lenses.
Two Republican congressmen introduce legislation to allow terminally ill patients to receive drugs that have passed FDA Phase 1 safety testing but are...
FDA warns Chinas Implant Dental Technology Co. about Quality System violations in its manufacturing of dental restorations and partial and full dentur...
Vertice Pharma asks FDA to require specific risk assessments for all potassium chloride oral products for human use.