FDAsafety guidance72% confidence
FDA AP — INQOVI (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (melanoma) as Regeneron.
Regulatory Analysis
Application NDA212576. Sponsor: TAIHO ONCOLOGY. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: CEDAZURIDINE, DECITABINE.
Supporting Context
- Therapeutic area
- Oncology · Melanoma
- Sub-indication
- Melanoma
Related signal: CMP-001 and Nivolumab Show Promise in Advanced Melanoma Phase 2/3 Trial
Source
FDA document
View source