Breakthrough Status Arrives Late In Development Of Yervoy+Opdivo, Enfortumab Vedotin And Pedmark
US FDA's latest BTD awards go to Seattle Genetics and Astellas' antibody-drug conjugate for immunotherapy-experienced urothelial cancer, Fennec's supportive care product to reduce cisplatin ototoxicity in pediatric cancer patients, and Bristol's double immunotherapy combo in MSI-H colorectal cancer.
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The latest news on novel drug approvals and complete response letters from our US FDA Performance Tracker.
The latest drug development news and highlights for our US FDA Performance Tracker.
Priority review announcements saw significant dip in third quarter 2018, while they usually experience a spike during the period; breakthrough therapy designations remained in double digits.