Category - New Drug Applications
FibroGen Announces U.S. FDA Acceptance of New Drug Application for Roxadustat for the Treatment of Anemia of Chronic Kidney Disease
Athenex Announces FDA Acceptance for Filing of U.S. NDA for Tirbanibulin Ointment in Actinic Keratosis
Alnylam Completes Rolling Submission of New Drug Application to the U.S. Food and Drug Administration and Submits Marketing Authorization Application to the European Medicines Agency for Lumasiran for the Treatment of Primary Hyperoxaluria Type 1
Y-mAbs Announces Submission of Naxitamab Biologics License Application to U.S. FDA
Seattle Genetics Announces FDA Filing Acceptance for Priority Review of Tucatinib New Drug Application (NDA) for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer
Eton Pharmaceuticals Provides Update on ET-105 Program
Zogenix Announces FDA Extension of Review Period for Fintepla in Dravet Syndrome
U.S. FDA Accepts Regulatory Submission for Tanezumab, a Potential First-in-Class Treatment for Patients with Chronic Pain Due to Moderate-to-Severe Osteoarthritis