Upcoming FDA decision · February 9, 2027
Mosunetuzumab PDUFA date: FDA decision expected February 9, 2027
179 days to goRoche Holding AG (RHHBY) →
The FDA is expected to decide on Mosunetuzumab from Roche Holding AG in Non-Hodgkin Lymphoma by the PDUFA target action date of February 9, 2027. For Relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL). sBLA filing. AI-extracted from news: FDA accepts supplemental Biologics License Application for Roche’s Lunsumio and Polivy combination f
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
February 9
Target action date
Phase 3
Stage
Verified
Date confidence
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FDA designations