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 News
    • Trending
    • Commercial Operations
    • GMPs
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews
  • Device News
    • Trending
    • Commercial Operations
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews
  • Books
    • FDAnews Books Library
    • Drug Books
    • Device Books
  • Training/Events
    • Webinar Training Pass
    • Events
    • Webinar Recordings
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
  • CenterWatch
  • WCG Clinical
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Imfinzi sBLA for Nonsmall-Cell Lung Cancer Hits Snag in AdComm

Imfinzi sBLA for Nonsmall-Cell Lung Cancer Hits Snag in AdComm

July 26, 2024
Drugs Regulatory Affairs
A supplemental BLA for AstraZeneca’s blockbuster cancer drug Imfinzi (durvalumab) for treatment of nonsmall-cell lung cancer (NSCLC) hit a potential speed bump Thursday in a review by the FDA’s oncology advisory panel of the supporting clinical trial.

To View This Article:

Login

Register
Forgot your password?

Subscribe To FDAnews

Buy This Article Now

Add this article to your cart for $25.00

Upcoming Events

  • 21Oct

    MAGI@home Clinical Research Conference 2024

Featured Products

  • FDA, FTC and DOJ Enforcement of Medical Device Regulations

    FDA, FTC and DOJ Enforcement of Medical Device Regulations

  • Using Real-World Evidence in Drug and Device Submissions

    Using Real-World Evidence in Drug and Device Submissions

Featured Stories

  • Risk of 10 Obesity-Driven Cancers Reduced by GLP-1s, Study Says

  • Three Device Areas Added to CDRH’s Device-Advancing TAP Program

  • Third Alzheimer’s Drug Gets FDA Approval, Just as Diagnostic Criteria Expand

  • Draft Guidance Covers Using URRAs in Combo Product Applications

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

212 Carnegie Center, Suite 301, Princeton, NJ 08540, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2024. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing