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Building a Regulatory Roadmap for IND, NDA, and BLA
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-10Mar 26, 2024
Regeneron
Priority Review

FDA Accepts for Priority Review Biologics License Application for REGN-EB3 to Treat Ebola

Regeneron

PR-M04-20-NI-025Apr 17, 2020
Astellas
BLA

Astellas and Seattle Genetics Announce Submission of Biologics License Application to FDA for Enfortumab Vedotin

Astellas

PR-M07-19-NI-050Jul 19, 2019
Merz Worldwide
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-062Mar 16, 2018
Merck & Co.
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-055Mar 15, 2018
Pfizer’s MYLOTARG Demonstrates Favorable Profile
ADC

Pfizer’s MYLOTARG Demonstrates Favorable Profile

Emilie Branch

Pharma's Almanac

PAO-M07-17-NI-022Jul 18, 2017
Amgen’s Vectibix Approved for RAS Metastatic Colorectal Cancer
FDA Approval

Amgen’s Vectibix Approved for RAS Metastatic Colorectal Cancer

Guy Tiene

Nice Insight

PAO-M07-17-NI-010Jul 11, 2017
FDA Approves Celltrion/Teva BLA for Rituximab Biosimilar
Biosimilars

FDA Approves Celltrion/Teva BLA for Rituximab Biosimilar

Guy Tiene

Nice Insight

PAO-M07-17-NI-006Jul 07, 2017
Priority Review Given to Kite’s Axicabtagene Ciloleucel
Clinical Trials

Priority Review Given to Kite’s Axicabtagene Ciloleucel

Nice Insight

PAO-M05-17-NI-034May 31, 2017
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