New oncologics bring CDER’s novel agent approvals count to 53 for the year.
The US FDA bracketed the Thanksgiving holiday with two new molecular entity approvals (NMEs) in oncology – Pfizer Inc.’s Daurismo (glasdegib) on Nov. 21 and Loxo Oncology Inc. and Bayer AG’s Vitrakvi (larotrectinib) on Nov. 26 – bringing the Center for Drug Evaluation and Research’s (CDER's) novel agent count for 2018 to a record-tying 53 approvals.
CDER is likely to reach 54 approvals by the end of November, further solidifying 2018 as the best year ever...
<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>
