New Drug Application submitted to the FDA for vadadustat for the anaemia due to chronic kidney disease in adult patients on dialysis and not on dialysis

The application for regulatory review of this oral hypoxia-inducible factor prolyl hydroxylase inhibitor was based on data from 36 trials involving >8,000 patients. The FDA has a 60-day period to determine whether the application is complete and acceptable for review.

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Biospace Inc.