Keeping Track: Pfizer’s Talzenna Ensures Record Year For Novel US Approvals; Novartis Submits SMA Gene Therapy

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

Keeping Track Feature image

Here's your US review and approval news this week in brief: The FDA’s Center for Drug Evaluation and Research matched 2017’s record novel approval count on Oct. 16 with the approval of Pfizer Inc.’s oncologic Talzenna.

Talzenna brings CDER’s new molecular entity and novel therapeutic biologic approval tally to 46 for 2018. Barring an unprecedented spurt of complete response letters for the rest of the year,...

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