GlaxoSmithKline (GSK +0.5%) and Theravance (THRX -1.7%) say their New Drug Application for...

|About: GlaxoSmithKline (GSK)|By:, SA News Editor

GlaxoSmithKline (GSK +0.5%) and Theravance (THRX -1.7%) say their New Drug Application for UMEC/VI, a treatment for patients with chronic obstructive pulmonary disease, has been accepted by the FDA, giving it the go-ahead for a substantive review. The PDUFA goal date has also been set for December 18, 2013.