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Home » FDA Denies Akebia’s Vadadustat Appeal but Suggests a Path Forward
FDA Denies Akebia’s Vadadustat Appeal but Suggests a Path Forward
Persisting first through an FDA complete response letter (CRL), and then through a denial of a formal dispute resolution request, Akebia Pharmaceuticals is now counting on Japanese postmarketing safety data to get vadadustat, its chronic kidney disease (CKD) anemia drug, over the finish line in the U.S.