We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » CBER Touts Gene Therapy, Vaccine Approvals in FY2018

CBER Touts Gene Therapy, Vaccine Approvals in FY2018

April 24, 2019

CBER Director Peter Marks highlighted two gene therapy approvals in a report on the center’s achievements for fiscal 2018.

The two gene therapy approvals were for Spark Therapeutics’ Luxturna (voretigene neparvovec-rzyl), for treatment of an inherited retinal disease, and Gilead’s Yescarta (axicabtagene ciloleucel), for treatment of certain types of adult, large B-cell lymphoma.

Marks called the year “particularly exciting because of the pace of progress in cellular and gene therapies,” noting that the center received more than 150 INDs for gene therapy products, raising the total count of active INDs to nearly 800 applications.

View today's stories

Pharmaceuticals Regulatory Affairs

Upcoming Events

  • 01Feb

    The Future of QMS: Will the Recent Announcement and Delays Have a Global Impact?

  • 08Feb

    Process and Design Validation for Devicemakers: A Deep Dive into Best Practices, Recent Trends and Regulatory Definitions

  • 09Feb

    The Inextricable Link Between Data Integrity and Quality Culture

  • 15Feb

    Advanced Compliance Writing CAPA: Mastering Failure Investigation and Root Cause Analysis

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 22Feb

    Best Practices for Developing and Maintaining a GxP Training Matrix

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • BioVentrix gets Expanded Access Approval for Left Ventricle Support System

  • FDA Approves Stemline’s Orserdu for Several Forms of Breast Cancer

  • FDA Issues Update on LivaNova Recall of Blood Pumping System

  • EU Expands Dupixent’s Authorization to Include Eosinophilic Esophagitis

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell or Share My Data
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing