US FDA clears first MASH (formerly NASH) therapy, nearly four years after one had been initially anticipated. With the accelerated approval path established, Madrigal gets the opportunity to create a marketplace with Rezdiffra (resmetirom), and candidates in the pipeline get a clear target.
With US Food and Drug Administration approval of Rezdiffra (resmetirom) for metabolic-associated steatohepatitis (MASH) with fibrosis, Madrigal Pharmaceuticals, Inc. now faces the challenge of developing the market for MASH, while it awaits competitors who will claim to offer efficacy, safety and/or tolerability advantages.
The FDA granted accelerated approval 14 March for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH, also known as...
<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>
<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>
<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>
<p>Executive Summary</p> <p>Zanidatamab, Jazz and BeiGene’s investigational treatment for biliary tract cancer, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.</p>
<p>Executive Summary</p> This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
<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>
