Page updated ·next FDA decision on the calendar·Data as of Oct 24, 2026 5:46 PM ET
FDA decision (PDUFA) target November 2026 · Roche Holding AG · Primary membranous nephropathy (pMN) in adults
Also under FDA review from Roche Holding AG, as a separate application: Gazyva, Dec 2026. One application, one page; this page is the application with the Nov 2026 goal date.
Key facts
FDA PDUFA target dateNovember 2026 (window)
Drug / candidateGazyva (obinutuzumab)
IndicationPrimary membranous nephropathy (pMN) in adults
The FDA PDUFA target date for RHHBY (Roche Holding AG) is November 2026 for Gazyva (obinutuzumab). The sponsor has guided this window, not a specific day; the date shown is the window, at the precision the source gave. Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is RHHBY's drug Gazyva?
Gazyva (obinutuzumab) is Roche Holding AG's candidate under FDA review for Primary membranous nephropathy (pMN) in adults.