FDAsafety guidance72% confidence
Ongoing | Cancer Accelerated Approvals
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (cardiology) as Novo Nordisk.
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
- Cardiology · Heart Failure
- Sub-indication
- Hypertension
Related signal: Novo Nordisk's NNC0487-0111 Trial Targets Heart Failure with Obesity