NeurogesX files NDA for dermal capsaicin patch
NeurogesX anticipates that the application, which is subject to acceptance by the FDA, will be subject to a standard review with a Prescription Drug User Fee Act date
Swedish Orphan Biovitrum (Sobi) has received a complete response letter from the US Food and Drug Administration (FDA) regarding its biologics licence application for nanoencapsulated sirolimus plus pegadricase (NASP), an investigational therapy intended for adults with uncontrolled gout.