Category - New Drug Applications
Zosano Announces FDA Submission of New Drug Application for Qtrypta
Urovant Sciences Announces Submission of New Drug Application for Vibegron for the Treatment of Overactive Bladder
Immunomedics Announces FDA Acceptance for Filing of Biologics License Application Resubmission for Sacituzumab Govitecan to Treat Metastatic Triple-Negative Breast Cancer
Nektar Issues Statement Regarding FDA Advisory Committee Vote for Oxycodegol
Chiasma Announces FDA Acceptance of Mycapssa New Drug Application Resubmission
Alnylam Initiates Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Lumasiran for the Treatment of Primary Hyperoxaluria Type 1 (PH1)
Nabriva Therapeutics Resubmits New Drug Application for Intravenous Contepo (fosfomycin) for Injection
Sunovion Announces FDA Filing Acceptance of Resubmitted New Drug Application for Apomorphine Sublingual Film