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CSL’s positive Phase 3b ANDEMBRY results support planned regulatory filings for garadacimab-gxii in children aged 2 to 11 with hereditary angioedema. Representative image.

Pharma & Biotech

CSL plans expanded pediatric ANDEMBRY filing after positive garadacimab Phase 3b data

by Pallavi Madhiraju
July 28, 2026
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CSL’s pediatric ANDEMBRY data support filings in children aged 2 to 11, but regulators still need full safety, PK and efficacy results.

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clinical trials Eli Lilly and Company European Medicines Agency FDA FDA approval immuno-oncology immunotherapy Inc. Johnson & Johnson medical devices oncology precision oncology rare disease U.S. Food and Drug Administration United States Food and Drug Administration

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