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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After US Woes, Akebia Celebrates EU Nod For Vafseo
The US biotech is in the throes of an appeal to the FDA against the rejection of its HIF-PH inhibitor but regulators in the EU have looked more kindly on vadadustat, which will be sold as Vafseo.
GSK Confident Its ‘Last Drug Standing’ In Anemia Class Can Gain US Panel Backing
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