US FDA accepts supplemental new drug application for Jardiance for adults with chronic kidney disease
The supplemental New Drug Application is based on results from the landmark EMPA-KIDNEY phase III trial
The supplemental New Drug Application is based on results from the landmark EMPA-KIDNEY phase III trial
Phase III trial also demonstrated a statistically significant reduction (14%) in hospitalization for any cause, bringing potential relief for patients and reducing burden on healthcare systems
Follows Zealand Pharma’s appointment of Adam Steensberg as CEO and decision to refocus strategy
Participants taking tirzepatide lost up to 52 lb. (24 kg) in this 72-week phase 3 study
Under the terms of the agreement, Bachem will provide the appropriate engineering infrastructure and expertise to implement Lilly’s novel oligonucleotide manufacturing technology
The breakthrough approval expands the existing indication of Jardiance to include adults with heart failure with preserved ejection fraction (HFpEF), an underserved patient population that previously had no approved therapies in Europe
Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death or hospitalization for heart failure, regardless of ejection fraction
Bebtelovimab neutralizes Omicron as demonstrated by pseudo virus and authentic virus data
Despite the challenges of pandemic disruptions, drug developers advance promising therapies for conditions, including Alzheimer's, diabetes and asthma
Expanded EUA includes both treatment of patients with Covid-19 and post-exposure prophylaxis (PEP) in high-risk pediatric and infant patients
Subscribe To Our Newsletter & Stay Updated