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FDA accepts Aimmune's peanut allergy therapy for review
March 18, 2019 8:13 PM UTC
Aimmune said the recent government shutdown may add about a month onto the approval timeline for its peanut allergy therapy. On Monday, FDA accepted for review a BLA for AR101 to treat peanut allergy in children and adolescents ages 4-17.
Aimmune Therapeutics Inc. (NASDAQ:AIMT) told BioCentury that while it submitted the BLA before the shutdown on Dec. 21, the 12-month standard review timeline began after the government re-opened in late January. Therefore, FDA's review may take until late January 2020...
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