CSL plans expanded pediatric ANDEMBRY filing after positive garadacimab Phase 3b data
CSL’s pediatric ANDEMBRY data support filings in children aged 2 to 11, but regulators still need full safety, PK and efficacy results.
Pharma & Biotech
Pharma & Biotech
FDA fast track for Argo Biopharma’s BW-20805 siRNA puts HAE’s next competitive battleground in focus
Argo Biopharmaceutical Co., Ltd. (Argo Biopharma), a Shanghai-based clinical-stage RNA interference therapeutics company, has received Fast Track Designation from the U.S. Food and Drug Administration for BW-20805, its investigational small interfering RNA therapy targeting prekallikrein for the prevention of hereditary angioedema attacks. The designation comes as the company runs a global Phase II open-label study