FDAsafety guidance72% confidence
FDA AP — VABYSMO (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (ophthalmology) as Roche.
Regulatory Analysis
Application BLA761235. Sponsor: GENENTECH INC. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: FARICIMAB-SVOA.
Supporting Context
- Therapeutic area
- Ophthalmology · Retinal Diseases
- Sub-indication
- Ophthalmology
Related signal: Roche Presents New Data on Vabysmo and Susvimo at ARVO 2026