In an interview with PharmaShots, Bradley Galer, M.D., Chief Medical Officer at Zogenix shed light on data supporting the regulatory application and what the EU approval of Fintepla will mean […]readmore
Tags : fenfluramine
Shots: The US FDA’s approval is based on two P-III studies assessing Fintepla vs PBO in patients aged ≥2yrs. with Dravet syndrome and a safety data from an OLE trial […]readmore
Shots: The NDA is based on two P-III studies and an interim analysis from an ongoing OLE study which includes assessing Zogenix in 232 patients with Dravet syndrome for up […]readmore