New Drug Applications Archive - September 2013
Get news by email or subscribe to our news feeds.
September 3, 2013
- Simultaneous Applications Submitted to FDA and EMA for Siltuximab for the Treatment of Multicentric Castleman Disease, a Rare Blood Disorder
- BHR Pharma Announces SyNAPSe® Trial Completes Patient Enrollment
- Totality of Data From Three Phase III Trials of The Medicines Company's Intravenous Cangrelor Presented and Published
September 4, 2013
- Takeda's New Investigational Drug Vedolizumab is Granted Priority Review Status by U.S. Food and Drug Administration for Ulcerative Colitis
- Chelsea Therapeutics Announces FDA Acceptance of Northera (droxidopa) NDA Resubmission
September 5, 2013
September 9, 2013
September 10, 2013
- FDA Advisory Committee Recommends Approval in U.S. of Umeclidinium/Vilanterol for the Treatment of COPD
- FDA Advisory Committee to Review Anoro Ellipta NDA
September 11, 2013
September 12, 2013
- Sanofi Provides Update on Lixisenatide New Drug Application in U.S.
- United Therapeutics Announces FDA Acceptance of Second Resubmission of Oral Treprostinil NDA
