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.
Akebia Therapeutics, Inc. found its hopes of getting a second product onto the market this year dashed as the US Food and Drug Administration turned down its approval application for vadadustat, a drug for anemia due to chronic kidney disease (CKD), citing safety concerns. The company will likely have to complete another trial to address the agency’s concerns.
Akebia – which is developing the drug under a partnership with Otsuka Pharmaceutical Co. Ltd. – announced 30 March...
The world’s biggest pharmaceutical companies mostly saw growth in 2024 but 2025 promises to be more of a mixed bag with headwinds including losses of exclusivity, Medicare Part D redesign and challenges in the Chinese market.
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Mounjaro, Eliquis, and Darzalex buck the Q1 trend to make gains
