Berinert C1-INH concentrate regulatory update

CSL said FDA approved an expanded label for acute hereditary angioedema (HAE) drug IV Berinert to allow self-administration and to include acute laryngeal attacks of HAE. The plasma-derived complement 1 (C1) esterase inhibitor is approved to treat acute abdominal and facial attacks of HAE. The product is approved in the U.S., Canada, Australia, Israel, Argentina, Japan, South Korea and 23 countries in Europe. ...