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FDA slaps FibroGen, AstraZeneca with last-minute roxadustat AdCom, cuing another delay for anemia drug

Mar 3, 2021 10:50am
The FDA has sent a last-minute notification of an advisory committee review of FibroGen and AstraZeneca s first-in-class anemia candidate roxadustat, threatening another decision delay. (FDA)
FibroGen and AstraZeneca already endured a delay in the U.S. review of their anemia candidate roxadustat. Just as the pair was expecting to snag its first-in-class approval, as the revised date draws near, a capricious FDA has stunned the companies with a second blow.
The FDA will convene an advisory committee to review roxadustat’s application for treating anemia caused by chronic kidney disease, both in patients who require dialysis and those who don’t, the two companies said Monday. ....

Geoffrey Porges , Andrew Berens , Johnson Epogen Procrit , Enrique Conterno , Difei Yang , Uncover Rare Disease Insights , Accelerate Commercialization , Improve Patient , New Fibrogen , Evrenzo Roxadustat , Fda Advisory Committee , Anemia Drugs , ஜெஃப்ரி போற்கேஸ் , ஆண்ட்ரூ பெரன்ஸ் , விரைவுபடுத்து வணிகமயமாக்கல் , மேம்படுத்த நோயாளி , இரத்த சோகை மருந்துகள் ,