U.S. FDA Grants Orphan Drug Exclusivity for Xywav® Oral Solution for Idiopathic hypersomnia (IH) in Adults
The United States Food and Drug Administration (FDA) has granted Orphan Drug Exclusivity (ODE) to Jazz Pharmaceuticals plc's Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution f ...
FDA Grants Orphan-Drug Exclusivity to Recorlev® for Endogenous Cushing’s Syndrome Treatment
Xeris Pharmaceuticals has revealed that the FDA has awarded orphan-drug exclusivity for its drug Recorlev® (levoketoconazole) for treating adult patients with endogenous Cushing's syndrome for whom su ...