Keeping Track: Ofev Snags SSc-ILD Indication, Accelerated Approval Reviews For Veverimer And Voxelotor, J&J Gets Its First Vaccine BTD
Executive Summary
The latest drug development news and highlights from our US FDA Performance Tracker.
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Boehringer Avoids Further Efficacy Study Of Ofev In SSc-ILD With Full Approval, No Post-Marketing Commitments
Despite concerns from members of US FDA's Arthritis Advisory Committee that the efficacy profile of Boehringer Ingelheim's Ofev needs more study in the SSc-ILD indication, the company does not have any such postmarketing requirements or commitments.
Global Blood Therapeutics' Voxelotor On Track For 2020 Sickle Cell Shakeup
The company's NDA for voxelotor was accepted by the US FDA for priority review with action expected in February, setting up a showdown with Novartis.