Recent And Upcoming FDA Advisory Committee Meetings
Executive Summary
Recent and upcoming FDA advisory committee meetings and a summary of topics covered.
You may also be interested in...
Sprout's Flibanserin Gets Reluctant Nod From FDA Panel, But REMS Needed
Advisory committee votes 18-6 to recommend approval of the female sexual dysfunction drug contingent on a risk management plan, despite unease about modest efficacy and risks such as fainting.
New EU Filings
Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Maxwellia Delivers Two UK Menstrual Health Rx-To-OTC Switches
UK switch specialist Maxwellia delivers two “me too” reclassifications in the area of women's health: Evana Heavy Period Relief and Ultravana Period Pain Relief.