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April 2, 2014
08:37 EDTKERXKeryx announces EMA validation of MAA for Zerenex
Keryx Biopharmaceuticals announced that the European Medicines Agency, or EMA, has determined that the company's Marketing Authorization Application, or MAA, seeking the approval of Zerenex as a treatment for hyperphosphatemia in patients with chronic kidney disease, CKD, including dialysis- and non-dialysis-dependent CKD, is valid. Validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process. The EMA's review of the application will follow the centralized marketing authorization procedure. If approved by the EMA, Zerenex will receive marketing authorization in all 27 member states of the European Union, as well as in Norway, Liechtenstein and Iceland.
News For KERX From The Last 14 Days
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October 1, 2014
07:34 EDTKERXKeryx issued new U.S. patent for Ferric Citrate
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September 29, 2014
07:34 EDTKERXKeryx initiates pivotal Phase 3 study of Ferric Citrate
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