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 (prostate cancer) as QLC Biotech.
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 · Prostate Cancer
- Sub-indication
- Prostate Cancer
Related signal: Phase Ib/II Trial of QLC5508 and QLH12016 in Advanced Prostate Cancer