U.S. FDA approves supplemental New Drug Applications to include landmark data in product labels for Synjardy® (empagliflozin/metformin hydrochloride), Synjardy® XR (empagliflozin/metformin hydrochloride extended-release) and Glyxambi® (empagliflozin/linag
U.S. FDA approves supplemental New Drug Applications to include landmark data in product labels for Synjardy® (empagliflozin/metformin hydrochloride), Synjardy® XR (empagliflozin/metformin hydrochloride extended-release) and Glyxambi® (empagliflozin/linag
US FDA accepts supplemental New Drug Application and grants Priority Review for Jardiance for adults with heart failure independent of left ventricular ejection fractio
US FDA accepts supplemental New Drug Application and grants Priority Review for Jardiance for adults with heart failure independent of left ventricular ejection fraction
FDA accepts sNDA for children/adolescents with fibrosing ILD
U.S. FDA accepts sNDA for OFEV® (nintedanib) for the potential treatment of children and adolescents aged 6-17 with fibrosing interstitial lung disease
FDA accepts Jardiance sNDA for T2D in children 10 and older
The US FDA has accepted a supplemental New Drug Application for Jardiance® (empagliflozin) tablets as a potential treatment for children 10 years and older with type 2 diabetes