WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or “the Company”) today announced that the Company has been issued a new patent related to its RYANODEX ® ...

WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)-- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle”) today announced that the Company has resubmitted its New Drug Application (“NDA”) for RYANODEX® (dantrolene ...

The discovery and subsequent introduction of dantrolene in 1979 was a major breakthrough in the treatment of malignant hyperthermia (MH) that is responsible for saving hundreds, if not thousands, of ...

In July 2017, Eagle had received a Complete Response Letter (CRL) from the FDA stating that an additional clinical trial would be needed prior to approval for the indication. The New Drug Application ...

WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)-- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that the U.S. Food and Drug ...

The Food and Drug Administration (FDA) has accepted and granted Priority Review to the New Drug Application (NDA) of Ryanodex (dantrolene sodium; Eagle) for the treatment of exertional heat stroke ...

-- Novel Antidote Enables Quicker Response to Inherited Life-Threatening Condition ---- Orphan Drug Designation may Provide Eagle Seven Years Market Exclusivity ---- First Self Marketed Drug for Eagle ...

Eagle Pharmaceuticals, Inc. EGRX announced that it has completed the submission of its 505(b)(2) New Drug Application (NDA) in the U.S. for Ryanodex. The company is looking to get Ryanodex approved ...

Nearly three years after an FDA rejection of Eagle Pharmaceuticals Inc.'s initial effort to add exertional heat stroke (EHS) to the list of approved indications for Ryanodex (dantrolene sodium), its ...

In keeping with its efforts to expand its product portfolio, Eagle Pharma announced last week that the new drug application for the company’s candidate dantrolene will be reviewed on a priority basis ...