The FDA designates AstraZeneca’s (NYSE:AZN) Farxiga (dapagliflozin) for Fast Track review to delay the progression of renal failure and prevent cardiovascular (CV) and renal death in patients with chronic kidney disease (CKD).
Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.
Shares are down 1% premarket on light volume.
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