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FDA Removes Clinical Hold on BioCryst's BCX 4161 -8K


On July 31, 2013, BioCryst Pharmaceuticals, Inc. (“BioCryst”) was notified by the United States Food and Drug Administration (“FDA”) that the Clinical Hold placed on its hereditary angioedema drug BCX 4161 has been removed. The FDA notified BioCryst that the Complete Response submitted by BioCryst to address the Clinical Hold satisfactorily addressed the FDA's concerns. This notification by the FDA provides BioCryst the ability to initiate BCX 4161 clinical trials in the United States and/or include U.S. clinical sites in its BCX 4161 clinical trials.

Posted-In: News FDA Movers


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