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AZN - FibroGen's Anemia Drug Goes to FDA for Review
AstraZeneca PLC
Biotech company FibroGen(NASDAQ: FGEN) announced Tuesday that its New Drug Application for drug candidate roxadustat, which treats anemia stemming from chronic kidney disease, has been accepted by the Food and Drug Administration.
The regulator has fixed a Prescription Drug User Fee Act (PDUFA) date of Dec. 20 of this year, effectively setting that as the deadline by which it must complete its review.