FDAapproval95% confidence
Withdrawn | Cancer Accelerated Approvals
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable approval decision relevant to Novartis; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been subsequently withdrawn, and are therefore, no longer FDA-approved.
Supporting Context
- Therapeutic area
- Nephrology · Complement Inhibition
- Sub-indication
- General
Related signal: Novartis Fabhalta® (iptacopan) gains FDA approval for primary IgAN treatment