The FDA has approved Ryanodex (dantrolene sodium), from Eagle Pharma, for injectable suspension indicated for the treatment of Malignant Hyperthermia...
Eagle Pharmaceuticals has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding its 505(b)(2) New...
Eagle Pharmaceuticals, Inc. has announced that the FDA has accepted the company's New Drug Application for Ryanodex (dantrolene) and granted...
Eagle Pharma has received a further Complete Response Letter for its New Drug Application (“NDA”) for Ryanodex for the treatment of exertional heat stroke (“EHS”). Eagle has decided that it will no longer pursue this indication.