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
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Fasting glucose improved by 12.3 mg/dL, while liver stiffness dropped 23.7%, signaling a direct hepatic benefit
The approval introduces a needle-free alternative to injectable GLP-1 therapies
The approval is supported by data from three pivotal clinical trials
The trials did not show a statistically significant reduction in annualized clinical fracture rates compared to placebo or bisphosphonates
The interim efficacy readout, involving around 170 participants with 15-month data, remains on track for the end of March 2026
Despite some promising subgroup signals, the company indicated it will not pursue further psychiatric trials
Wayrilz represents a new approach to ITP by targeting the disease at its root through multi-immune modulation
The approval makes AQVESME the only FDA-approved therapy for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia
The decision is based on robust clinical evidence from the VOYAGE and EXCURSION studies
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