Gazyva (obinutuzumab) is a Roche Holding AG program in frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome in patients 2 years and older who are in remission (reduce the risk of relapse). The FDA approved it on Sep 25, 2026. 1 FDA decision on record below. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
FDA approval tracked on pdufa.bio: frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome in patients 2 years and older who are in remission (reduce the risk of relapse) (approved Sep 25, 2026). Earlier approvals may not be listed here; the FDA label is the full record. Sponsor: Roche Holding AG (RHHBY). Approval record: Supplemental BLA (efficacy) approved September 25, 2026 with Breakthrough Therapy, Orphan Drug and Priority Review designations (FDA notice). Phase 3 INShore (NCT05627557), 85 patients aged 2 and older, Gazyva versus mycophenolate mofetil. Gazyva was previously approved for certain cancers and for adults with active lupus nephritis. Market-cap tier at the time we tracked it: Large. We track 1 catalyst event for this program: 0 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
No upcoming catalyst is on our calendar for Gazyva (obinutuzumab); 1 FDA decision is on record below.
On Sep 25, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
In our records Gazyva (obinutuzumab) is FDA-approved for frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome in patients 2 years and older who are in remission (reduce the risk of relapse) (approved Sep 25, 2026). Other approved uses may not be tracked here; the FDA label is the full record.
Roche Holding AG (RHHBY).
Yes. The FDA approved an application for Gazyva (obinutuzumab) on Sep 25, 2026; the decision page linked above carries the source.
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.