Keeping Track: Kite’s Tecartus Is Third CAR-T With US FDA Approval; Submissions Round-Up
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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After missing user fee date due to inspection delay, US FDA clears the CAR-T therapy for treatment of adults with relapsed or refractory large B-cell lymphoma.
Coming year could feature first-time approvals in the EU for at least five gene therapies.
The sponsors of 11 new treatments should learn this week whether the European Medicines Agency will recommend EU marketing approval for their products.