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Keeping Track: Bristol Tests US FDA’s TMB Tolerance, Celltrion Resubmits Herceptin Biosimilar, Nocdurna Approved At Last

 
• By Michael Cipriano and Bridget Silverman

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

Immuno-oncology continues to keep FDA’s oncology staff occupied, with last week bringing news that Bristol-Myers Squibb Co.’s Opdivo/Yervoy combination is under review for a first-line non-small cell lung cancer indication that poses the first regulatory test of the emerging tumor mutation burden (TMB) biomarker.

The agency also received a biologics license application (BLA) for Alexion Pharmaceuticals Inc

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