Kite's Gene Therapy Yescarta Gets Biosimilar Treatment With Second-In-Class Approval
Much like it did for the first biosimilars, US FDA approved Yescarta without an advisory committee, as Novartis' first-in-class CAR-T cell therapy already set the stage for an agency review.
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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
The latest drug development news and highlights from our US FDA Performance Tracker.
CBER Director Peter Marks says the center implemented a lot in a short amount of time for the RMAT pathway.