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Keeping Track: Rybrevant Goes RTOR, Two-Part Review For Dasiglucagon, And CRL For Ultomiris

 
• By Bridget Silverman

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Keeping Track Feature image

The month of September started out quietly in terms of approvals, but submission activity continued at a smart pace.

Rare diseases are prominent among the recent applications, which include a first-line biomarker-defined non-small cell lung cancer filing from Johnson & Johnson for the bispecific Rybrevant, indications in inherited primary immunodeficiencies for X4 Pharmaceuticals’s mavorixafor and

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