FDAsafety guidance83% confidence
Ongoing | Cancer Accelerated Approvals
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Regeneron.
Regulatory Analysis
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have postmarketing requirement(s) for ongoing clinical trial(s) to verify clinical benefit.
Supporting Context
- Therapeutic area
- Hematology · Paroxysmal Nocturnal Hemoglobinuria (PNH)
- Sub-indication
- General
Related signal: Regeneron initiates trial for pozelimab + cemdisiran in PNH patients unresponsive to C5 inhibitors