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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The company announced positive Phase II data for roxadustat in chemotherapy-induced anemia.
The EU approval is good news for FibroGen and marketing partner Astellas, but was expected, and still leaves it pondering its future after FDA knock-back.
Keeping Track: Merck & Co. In Spotlight With Welireg, Keytruda Approvals; FibroGen/AZ Roxadustat CRL Is No Surprise
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.