FDAsafety guidance66% confidence
FDA AP — OCREVUS ZUNOVO (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Roche; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application BLA761371. Sponsor: GENENTECH INC. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: OCRELIZUMAB AND HYALURONIDASE-OCSQ.
Supporting Context
- Therapeutic area
- Neurology · MS
- Sub-indication
- General
Related signal: FDA Accepts Supplemental BLA for OCREVUS ZUNOVO by Genentech