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FDA and EMA Accept CSL’s Filings for CSL312 (garadacimab)

Dec 14, 2023

CSL announced that the FDA accepted its Biologics License Application (BLA), and the EMA has accepted its Marketing Authorisation Application (MAA), for CSL312 (garadacimab) to treat prophylactic treatment for hereditary angioedema (HAE).  If approved, CSL312 would be the first treatment for HAE in the US and Europe to target activated Factor XII.