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 » Health Canada Clears Reblozyl for Myelodysplastic Syndromes

Health Canada Clears Reblozyl for Myelodysplastic Syndromes

February 18, 2021

Bristol Myers Squibb and Acceleron Pharma have received Health Canada’s approval for Reblozyl (luspatercept) for treating adults with a specific type of myelodysplastic syndromes (MDS).

MDS are cancers that hinder the bone marrow’s ability to produce healthy red blood cells, usually occurring in older individuals, especially men.

The approval was supported by positive phase 3 trial results for patients with MDS requiring regular blood transfusions. The trial found that 38 percent of patients receiving Reblozyl achieved transfusion independence for eight weeks or more at week 24 vs. only 13 percent in the placebo arm.

View today's stories

Pharmaceuticals Submissions and Approvals

Upcoming Events

  • 10Mar

    FDA Drug GMP Facility Inspections During the Pandemic

  • 16Mar

    Pharmaceutical Naming Regulation: Understanding the Latest Developments

  • 18Mar

    Pharmaceutical Postmarket Surveillance: Latest Developments in the Era of COVID-19

  • 23Mar

    Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

  • 30Mar

    Data Integrity for GMP/Postmarket Professionals: Core Requirements, Expectations and Challenges

  • 06Apr

    Medical Device Cybersecurity: Understand the Latest Developments

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • AstraZeneca

    AstraZeneca Withdraws Imfinzi’s Bladder Cancer Indication

  • CE mark

    Cue Health’s COVID-19 Test Receives CE Mark

  • Sanofi-Regeneron_Logos.png

    Sanofi’s and Regeneron’s Libtayo Wins FDA Approval for NSCLC

  • PerkinElmer logo

    PerkinElmer’s Rapid Point-of-Care COVID-19 Test Cleared in Europe

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