Human clinical trial commences for first leprosy vaccine candidate
Characterized by the World Health Organization as a "neglected tropical disease," leprosy (also known as Hansen's disease) is one of the most ancient diseases known to humankind and
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.
Currently, there are no FDA approved treatments for patients with non-metastatic CRPC. This submission is based on Phase 3 data from the pivotal ARN-509-003 (SPARTAN) clinical trial, which