New EU Approvals

 
• By Neena Brizmohun
  
Generate a summary of this article
Listen to this article
Beta

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add seven new products, including Janssen-Cilag’s Rybrevant for treating patients with advanced non-small cell lung cancer.

The Pink Sheet’s regularly updated list of products containing new active substances that have been approved for marketing in the EU under the centralized authorization procedure now includes seven new products – Nuvaxovid (COVID-19 Vaccine (recombinant, adjuvanted)), Xevudy (sotrovimab), Aspaveli (pegcetacoplan), Vaxneuvance (Pneumococcal polysaccharide conjugate vaccine (15‑valent, adsorbed)), Cibinqo (abrocitinib), Rybrevant (amivantamab) and Artesunate Amivas (artesunate).

The list, which contains information dating back to January 2018, comprises brand name, generic name, company, therapeutic indication, date of...

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

SpotifyApple PodcastsWebsite

More from Europe

  • EU Biosimilar Filings, Opinions And Approvals

     
    • By Saba Afreen

    <p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>

  • EU Pharma Reform: What You Need to Know Now

     
    • By Anabel Costa-Ferreira and Ian Schofield

    As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.

  • New EU Approvals

    <p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>

More from Geography