FDA New Drug Applications

February 23, 2016

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Nektar Issues Statement Regarding FDA Advisory Committee Vote for Oxycodegol
Source: FDA New Drug Applications Published on 2020-01-14
Chiasma Announces FDA Acceptance of Mycapssa New Drug Application Resubmission
Source: FDA New Drug Applications Published on 2020-01-13
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)
Source: FDA New Drug Applications Published on 2020-01-10
Nabriva Therapeutics Receives FDA Acknowledgement of New Drug Application Resubmission for Intravenous Contepo (fosfomycin) for Injection
Source: FDA New Drug Applications Published on 2020-01-08
Urovant Sciences Announces Submission of New Drug Application for Vibegron for the Treatment of Overactive Bladder
Source: FDA New Drug Applications Published on 2019-12-30
Immunomedics Announces FDA Acceptance for Filing of Biologics License Application Resubmission for Sacituzumab Govitecan to Treat Metastatic Triple-Negative Breast Cancer
Source: FDA New Drug Applications Published on 2019-12-26
Correvio Receives Complete Response Letter From U.S. FDA for Brinavess and Provides Update on Recent Events
Source: FDA New Drug Applications Published on 2019-12-24
Zosano Announces FDA Submission of New Drug Application for Qtrypta
Source: FDA New Drug Applications Published on 2019-12-23
FibroGen Submits New Drug Application to the U.S. FDA for Roxadustat in Patients With Anemia of Chronic Kidney Disease
Source: FDA New Drug Applications Published on 2019-12-23
BioMarin Submits Biologics License Application to U.S. Food and Drug Administration for Valoctocogene Roxaparvovec to Treat Hemophilia A
Source: FDA New Drug Applications Published on 2019-12-23
Seattle Genetics Announces Submission of Tucatinib New Drug Application to the U.S. FDA for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer
Source: FDA New Drug Applications Published on 2019-12-23
Nabriva Therapeutics Resubmits New Drug Application for Intravenous Contepo (fosfomycin) for Injection
Source: FDA New Drug Applications Published on 2019-12-20
Sunovion Announces FDA Filing Acceptance of Resubmitted New Drug Application for Apomorphine Sublingual Film
Source: FDA New Drug Applications Published on 2019-12-20
Evoke Resubmits Gimoti New Drug Application to FDA
Source: FDA New Drug Applications Published on 2019-12-20
Gilead Submits Filgotinib New Drug Application to U.S. Food and Drug Administration Under Priority Review for Rheumatoid Arthritis Treatment
Source: FDA New Drug Applications Published on 2019-12-19

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