Ascletis Pharma gets FDA nod for Phase II diabetes trial of oral GLP-1 drug
The trial’s primary endpoint is the mean change in HbA1c from baseline, while secondary endpoints include changes in fasting blood glucose, body weight, and overall safety
The trial’s primary endpoint is the mean change in HbA1c from baseline, while secondary endpoints include changes in fasting blood glucose, body weight, and overall safety
Mepolizumab is the first and only monthly biologic in China tested for COPD patients with blood eosinophil counts (BEC) as low as 150 cells/µL
Diffuse large B-cell lymphoma (DLBCL), the most common type of non-Hodgkin lymphoma (NHL) in adults, represents 40% of all cases worldwide
Pembrolizumab has shown meaningful benefit only when combined with chemotherapy
The company said it received notice on January 1 from the FDA’s Center for Veterinary Medicine that the funding will support its ongoing effectiveness study of Canalevia-CA1
The decision positions Yartemlea as the first and only approved inhibitor of the lectin pathway of complement
The FDA acknowledged that Corcept’s pivotal GRACE trial met its primary endpoint and that data from the GRADIENT trial offered confirmatory evidence
The approval is supported by data from three pivotal clinical trials
Elanco expects Befrena to launch in the US in the first half of 2026
The acquisition adds HLD-0915, a once-daily oral therapy for prostate cancer, to Johnson & Johnson’s nearly 20-year legacy of innovation in the disease
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