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Keeping Track: Early Thanks Given By ImmunoGen, Provention Bio; More PD-1/L1 Combo Approvals

 
• By Bridget Silverman

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

Keeping Track Feature image

With the end of 2022 in sight over the Thanksgiving holiday horizon, the US FDA drugs center brought its novel approvals count to 29 with the approvals of ImmunoGen, Inc.’s antibody-drug conjugate Elahere for a targeted ovarian cancer claim and Provention Bio, Inc.’s anti-CD3 antibody Tzield to delay onset of type 1 diabetes.

Both biologics face challenges to identifying patients for a new therapy setting. Elahere, the first folate receptor alpha (FRα)-targeting therapy for ovarian cancer, was cleared along with the first companion...

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