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FibroGen regains all rights to roxadustat from AstraZeneca in the United States and other AstraZeneca territories, except China and South Korea

Written by | 2 Mar 2024

FibroGen, Inc. announced that FibroGen and AstraZeneca have agreed to terminate the U.S./RoW roxadustat collaboration agreement entered into on July 30, 2013, under which AstraZeneca held development and… read more.

FibroGen receives Complete Response Letter from the FDA for roxadustat for anemia of chronic kidney disease – FibroGen + AstraZeneca

Written by | 22 Aug 2021

The FDA has issued a complete response letter (CRL) regarding the New Drug Application (NDA) for roxadustat for the treatment of anaemia of chronic kidney disease (CKD), in… read more.

FibroGen provides additional information on roxadustat to the FDA relating to U.S. primary cardiovascular safety analyses

Written by | 17 Apr 2021

FibroGen, Inc. has provided clarification of certain prior disclosures of U.S. primary cardiovascular safety analyses from the roxadustat Phase III program for the treatment of anemia of chronic… read more.

The FDA will convene an Advisory Committee meeting to review the NDA for roxadustat to treat anemia of CKD – AstraZeneca + FIbroGen Inc

Written by | 7 Mar 2021

AstraZeneca and FibroGen, Inc. announced that the FDA informed FibroGen that it will convene a meeting of the Cardiovascular and Renal Drugs Advisory Committee to review the new… read more.

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