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Merck & Co has presented lots of data on its huge-earning checkpoint inhibitor at the Barcelona congress, the highlights being impressive first-time overall survival results for Keytruda in cervical cancer and early-stage triple-negative breast cancer.

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Vadadustat's review overlapped with two other oral HIF-PH class drugs. Safety issues with FibroGen/AstraZeneca’s roxadustat drew attention during vadadustat's first-cycle review, while GSK’s Jesduvroq labeling and postmarketing requirements informed the second-cycle approval.

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Akebia’s Vafseo: Japanese Postmarketing Data, Narrowed Indication Eased Liver Toxicity Worries

The Pink Sheet Drug Review Profile explores the US FDA’s approval of vadadustat to treat anemia in chronic kidney disease patients on dialysis. A complete response letter cited the risk of drug-induced liver injury, but postmarketing data from Japan reassured reviewers.

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Vafseo Chronology: Complete Response Letter, Dispute Resolution And A Second-Cycle Approval

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