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Priority Review
FDA Accepts for Priority Review Biologics License Application for REGN-EB3 to Treat Ebola
PR-M04-20-NI-025
BLA
U.S. FDA Accepts Biologics License Application (BLA) for Mylan and Biocon's Proposed Biosimilar Bevacizumab for Review
PR-M03-20-NI-014
BLA
Astellas and Seattle Genetics Announce Submission of Biologics License Application to FDA for Enfortumab Vedotin
PR-M07-19-NI-050
Biologics License Application
FDA Accepts for Filing Supplemental Biologics License Application (sBLA) for Xeomin® (incobotulinumtoxinA) in Adult Patients with Sialorrhea
PR-M03-18-NI-062
FDA
FDA Grants Priority Review to Merck’s Supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab) for Treatment of Advanced Cervical Cancer
PR-M03-18-NI-055
ADC
Pfizer’s MYLOTARG Demonstrates Favorable Profile
PAO-M07-17-NI-022
FDA Approval
Amgen’s Vectibix Approved for RAS Metastatic Colorectal Cancer
PAO-M07-17-NI-010
Biosimilars
FDA Approves Celltrion/Teva BLA for Rituximab Biosimilar
PAO-M07-17-NI-006
Clinical Trials
Priority Review Given to Kite’s Axicabtagene Ciloleucel
PAO-M05-17-NI-034
