FDA Approves sNDA for BI’s Stiolto® Respimat® | BI US
FDA approves an sNDA for STIOLTO® RESPIMAT® (tiotropium bromide & olodaterol) showing improvement in quality of life in COPD patients. View ISI, PI & Med Guide.
Full data announced in phase III EMPA-KIDNEY trial
The EMPA-KIDNEY phase III clinical trial met its primary endpoint by demonstrating a significant kidney and cardiovascular benefit for adults living with chronic kidney disease (CKD)
The FDA has approved Jardiance® (empagliflozin) tablets to reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease, cardiovascular death and hospitalization in adults with CKD at risk of progression.
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