Restructuring On The Table For FibroGen After Roxadustat Rejection
As anticipated, the FDA issued a complete response letter for roxadustat. While the drug is expected to win EU approval, it is unclear if FibroGen and AstraZeneca will be willing to fund another trial.
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GSK could have the US market to itself if it can convince the expert panel of daprodustat’s safety, as rivals have fallen by the wayside.
Keeping Track: Novel Oncologics Submitted By Taiho, ImmunoGen, Y-mAbs; US FDA Declines Akebia’s Vadadustat
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
The US FDA turned down approval for vadadustat in chronic kidney disease anemia, in a complete response letter that unexpectedly included the dialysis-dependent indication.