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Home » New orphan drug, CSL’s garadacimab, cleared for hereditary angioedema
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New orphan drug, CSL’s garadacimab, cleared for hereditary angioedema

June 17, 2025
By Karen Carey and Tamra Sami
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Following a complete response letter issued last October over CMC issues, CSL Behring LLC gained U.S. FDA approval June 16 of its humanized anti-factor XIIa monoclonal antibody, garadacimab (CSL-312), to prevent hereditary angioedema attacks.
BioWorld Regulatory Dermatologic Monoclonal antibody Asia-Pacific Australia U.S. FDA

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