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» 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.
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