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.
FDA approves a Genentech supplemental BLA for Susvimo (ranibizumab injection) 100 mg/mL for treating diabetic macular edema.
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.
FDA approves a Supernus Pharmaceuticals NDA for Onapgo (apomorphine hydrochloride) injection for treating motor fluctuations in adults with advanced P...