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3 articles with Asklepion Pharmaceuticals
Asklepion Pharma Announces Special Protocol Assessment (SPA) Agreement With FDA for Phase III Program of Intravenous Citrulline
This SPA provides agreement that the Phase 3 protocol design, notably clinical endpoints, trial population and statistical analyses adequately address objectives that, if met, would form the primary basis of an efficacy claim in support of a regulatory submission for approval of intravenous citrulline for the prevention of clinical sequelae of acute lung injury induced by cardiopulmonary bypass in pediatric subjects undergoing surgery for congenital heart defects.
Asklepion Release: CHOLBAM (cholic acid) Now Approved In The U.S. For Patients With Bile Acid Synthesis Disorders