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(RTTNews) - Akebia Therapeutics Inc. (AKBA) said Tuesday that it received a written response from the Office of New Drugs or OND of the U.S. Food ...
/PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney...
Akebia Therapeutics’ formal dispute resolution request was denied by the Office of New Drugs of the FDA for vadadustat in the treatment of anemia due to for dialysis-dependent patients, according to a press release.However, the response letter provided a path forward for the company to resubmit the new drug application.