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Latest From FibroGen China
Touted in China after its first approval globally there for chronic kidney disease-associated anemia back in late 2018, FibroGen/AstraZeneca's roxadustat has now been rejected by the US FDA over cardiovascular safety concerns. But ex-US markets may still enable the drug to shine despite safety wording.
The SOURCE failure is a reversal for the novel Amgen-partnered TSLP inhibitor after NAVIGATOR success last month, and comes just days after the US FDA requested more analyses of the pivotal data for the kidney disease anemia therapy roxadustat.