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US rejects AZ and FibroGen’s anaemia drug roxadustat pharmatimes
August 13, 2021
The US Food and Drug Administration (US) has handed AstraZeneca a complete response letter (CRL) regarding its anaemia drug roxadustat.
FibroGen Receives Complete Response Letter from the FDA for Roxadustat for Anemia of Chronic Kidney Disease drugs
August 12, 2021
FibroGen, Inc. (NASDAQ: FGEN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for roxadustat for the treatment of anemia of chronic kidney disease (CKD).
Update on US Regulatory Review of Roxadustat in Anaemia of Chronic Kidney Disease americanpharmaceuticalreview
August 12, 2021
The US FDA has issued a complete response letter (CRL) regarding the New Drug Application (NDA) for roxadustat for the treatment of anemia of chronic kidney disease (CKD), in both non-dialysis dependent (NDD) and dialysis-dependent (DD) adult patients.
AstraZeneca and FibroGen's roxadustat, not yet filed in U.S., nabs 2nd anemia nod in China fiercepharma
August 25, 2019
FibroGen has not even filed its AstraZeneca-partnered oral anemia drug roxadustat for U.S. approval. But the collaborators have already scored their second nod for the blockbuster hopeful in China.
AstraZeneca and FibroGen receive approval to market roxadustat in China pharmaceutical-technology
December 21, 2018
AstraZeneca and its partner FibroGen Medical Technology Development have obtained approval from China’s National Medical Products Administration (NMPA) to market roxadustat for the treatment of anaemia caused due to chronic kidney disease (CKD).....
AstraZeneca, FibroGen give China bragging rights to first-in-class anemia drug approval fiercepharma
December 20, 2018
It is a rare event, if not a singular one in the biopharma world: A first-in-class drug developed by multinational pharma companies was filed first—and now approved first—in China, well before the U.S., EU or Japan.