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.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » EMA Assessing Remdesivir for COVID-19 Expanded Indication

EMA Assessing Remdesivir for COVID-19 Expanded Indication

Remdesivir - drug
February 25, 2021

The European Medicines Agency (EMA) is evaluating remdesivir data submitted by Gilead Sciences to determine whether the antiviral’s indication should be expanded to cover adult COVID-19 patients who don’t need supplemental oxygen.

The agency’s recommendation, which it expects to provide before the summer, would need to be accepted by the European Commission, which will have the final say in authorizing or rejecting the proposed expanded indication.

The drug was granted conditional marketing authorization in the EU in July 2020 for treating COVID-19 in adults and adolescents with pneumonia who require supplemental oxygen. The EMA explained at the time that although there were less data than it would normally expect, the drug’s benefits appeared to outweigh its risks.

View today's stories

Pharmaceuticals Submissions and Approvals

Upcoming Events

  • 26Apr

    MAGI's Clinical Research vConference — Spring 2021

  • 06May

    The World of Post-COVID-19 Clinical Trials: How to Prepare for What’s Coming Next

  • 12May

    Extractables and Leachables: 101

  • 19May

    CDRH’s New Accreditation Scheme for Conformity Assessment: Impacts on Your Future Testing Plans and FDA Submissions

  • 25May

    How Can the Accelerated Availability of Pfizer-BioNTech’s COVID-19 Vaccine be Replicated?

  • 27May

    Evolving Clinical Trials: Continuing the Journey from Paper to Digital

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • Fujifilm_Logo.gif

    Fujifilm Begins Late-Stage Trial of Avigan for COVID-19

  • CE mark

    DiaSorin’s 10-Minute COVID-19 Antibody Test CE Marked

  • WHO

    WHO Will Review Two COVID-19 Vaccines from China

  • CE mark

    Qiagen’s High Throughput COVID-19 Test Earns CE Mark

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 My Personal Information
Footer Logo

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

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing