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Keeping Track: Ilumya, Adcetris Approved; Xtandi Priority Reviewed; Azedra Goal Date Extended

 
• By Michael Cipriano and Bridget Silverman

The latest drug development news and highlights from our US FDA Performance Tracker.

Keeping Track Feature image

A few big approvals stole the spotlight at the US FDA last week, including Sun Pharmaceutical Industries Ltd.'spsoriasis treatment Ilumya (tildrakizumab-asmn), which became the second biologic approved by the Center for Drug Evaluation and Research (CDER) and the sixth overall CDER-approved novel agent in 2018. It was also the first standard review novel approval of 2018.

Sharing the podium with Ilumya was Seattle Genetics Inc.'s Adcetris (brentuximab vedotin)‎, which scored a supplemental indication for the...

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