Published: Jun 01, 2021
CAMBRIDGE, Mass. and TOKYO, June 1, 2021 /PRNewswire/
Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease, and its collaborator,
U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application (NDA) for vadadustat for the treatment of anemia due to chronic kidney disease (CKD) in both adult patients on dialysis and adult patients not on dialysis.
The FDA has assigned the application standard review and a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2022. The FDA also indicated that they are not currently planning to hold an Advisory Committee meeting to discuss the application.
Zeposia the first and only oral sphingosine 1-phosphate receptor modulator approved for ulcerative colitis 1 represents a new way of treating this chronic immune-mediated disease 2 Zeposia demonstrated significant improvements across all primary and key secondary efficacy endpoints including clinical remission, clinical response, endoscopic improvement and endoscopic-histologic mucosal improvement versus placebo at .
Amgen today announced that the U.S. Food and Drug Administration has approved LUMAKRAS ™ for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer as determined by an FDA-approved test, who have received at least one prior systemic therapy. LUMAKRAS has received accelerated approval based on overall response rate and duration of response . Continued .