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IND, NDA, and BLA
Building a Regulatory Roadmap for IND, NDA, and BLA
Rebecca Lamb-Wharton, Ph.D.; Brenda Schlenk, RPh; Mamadou Diallo, PharmD
PAO-03-24-CL-10
Mar 26, 2024
Priority Review
FDA Accepts for Priority Review Biologics License Application for REGN-EB3 to Treat Ebola
Regeneron
PR-M04-20-NI-025
Apr 17, 2020
BLA
Astellas and Seattle Genetics Announce Submission of Biologics License Application to FDA for Enfortumab Vedotin
Astellas
PR-M07-19-NI-050
Jul 19, 2019
Biologics License Application
FDA Accepts for Filing Supplemental Biologics License Application (sBLA) for Xeomin® (incobotulinumtoxinA) in Adult Patients with Sialorrhea
Merz Worldwide
PR-M03-18-NI-062
Mar 16, 2018
FDA
FDA Grants Priority Review to Merck’s Supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab) for Treatment of Advanced Cervical Cancer
Merck & Co.
PR-M03-18-NI-055
Mar 15, 2018
ADC
Pfizer’s MYLOTARG Demonstrates Favorable Profile
Emilie Branch
Pharma's Almanac
PAO-M07-17-NI-022
Jul 18, 2017
FDA Approval
Amgen’s Vectibix Approved for RAS Metastatic Colorectal Cancer
Guy Tiene
Nice Insight
PAO-M07-17-NI-010
Jul 11, 2017
Biosimilars
FDA Approves Celltrion/Teva BLA for Rituximab Biosimilar
Guy Tiene
Nice Insight
PAO-M07-17-NI-006
Jul 07, 2017
Clinical Trials
Priority Review Given to Kite’s Axicabtagene Ciloleucel
Nice Insight
PAO-M05-17-NI-034
May 31, 2017
