Agency's Oncologic Drugs Advisory Committee had only discussed gemtuzumab as a treatment for adults with acute myeloid leukemia at its July meeting, but labeling includes a pediatric claim based on a 29-patient trial; drug returns to the US market after being withdrawn in 2010 for failure to confirm clinical benefit.
Pfizer Inc.'s acute myeloid leukemia (AML) drug Mylotarg (gemtuzumab ozogamicin) is heading back to the US market after being withdrawn in 2010, and FDA's re-approval comes with a bonus pediatric indication that was not discussed at a July advisory committee meeting.
FDA approved Mylotarg Sept. 1 for the treatment of adults with newly diagnosed AML whose tumors express the CD33 antigen,...
<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>
