Keeping Track: Breakthroughs Dominate 2017 Novel Agents; US FDA Approves Rydapt, Alunbrig, Tymlos, Brineura

 
• By Bridget Silverman
  
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The latest drug development news and highlights from our FDA Performance Tracker.

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Products awarded FDA's breakthrough therapy designation account for half of the novel agents approved by FDA's Center for Drug Evaluation and Research in 2017 after the clearance three BTD drugs in two days: Novartis AG's Rydapt and Ariad Pharmaceuticals Inc.'s Alunbrig, both oncologics, on April 28 and BioMarin Pharmaceutical Inc.'s orphan inherited disease therapy Brineura on April 27.

CDER's novel approvals count for 2017 stands at 18 new drugs and therapeutic biologics, including Rydapt, Alunbrig, Brineura, and a...

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