There isn’t any doubt about what will be the most hyped biomedical innovation approved by FDA in 2017.
The agency’s Aug. 30 approval of Novartis AG’ CAR-T anticancer treatment Kymriah has that honor locked down. (Also see...
It isn’t just the cutting-edge science. Novartis’ landmark approval also highlights regulatory and reimbursement innovation and also may set the rules that the next wave of cell and gene therapies have to follow.

There isn’t any doubt about what will be the most hyped biomedical innovation approved by FDA in 2017.
The agency’s Aug. 30 approval of Novartis AG’ CAR-T anticancer treatment Kymriah has that honor locked down. (Also see...
<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>