FDA agrees to an expedited pathway for Avanir Pharmaceuticals’investigational compound AVP-786, which is being developed for central nervous system disorders.
FDA accepts for priority review a Bristol-Myers Squibb and AstraZeneca BLA for metreleptin, an investigational agent for treating metabolic disorders associated with inherited or acquired lipodystrophy.
CDER’s Office of Prescription Drug Promotion says a Validus Pharmaceuticals Web page for Marplan is false and misleading due to unsubstantiated superiority claims and other violations.
A House Appropriations Committee mark up proposes to give FDA almost $100 million more in fiscal year 2014 than the current sequester-imposed budget authority.