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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.

CHMP positive for Jesduvroq to treat symptomatic anemia in adults with chronic kidney disease who are on dialysis – GSK

Written by | 7 Jul 2023

Jesduvroq (daprodustat) from GSK received a positive opinion from the CHMP for the treatment of adult patients for for the treatment of symptomatic anaemia in adults with chronic… read more.

EMA accepts marketing authorisation application for daprodustat to treat anaemia of chronic kidney disease – GSK

Written by | 26 Apr 2022

GlaxoSmithKline plc announced that the European Medicines Agency (EMA) validated the marketing authorisation application (MAA) for daprodustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the… read more.

European Commission approves Evrenzoto treat adult patients with symptomatic anemia associated with chronic kidney disease – Astellas + FibroGen Inc.

Written by | 1 Sep 2021

Astellas Pharma Inc.and FibroGen, Inc. announced that the European Commission (EC) has approved Evrenzo (roxadustat) for the treatment of adult patients with symptomatic anemia associated with chronic kidney… 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.

GSK announces positive headline results from five phase III studies of daprodustat for patients with anaemia due to chronic kidney disease

Written by | 28 Jul 2021

GlaxoSmithKline plc announced positive headline results from five studies of the Phase III ASCEND programme, evaluating the efficacy and safety profile of daprodustat, an investigational oral hypoxia-inducible factor… 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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