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 (ophthalmology) as Viridian Therapeutics.
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
- Ophthalmology · Thyroid Eye Disease
- Sub-indication
- Ophthalmology
Related signal: Viridian Therapeutics initiates trial for VRDN-003 in Thyroid Eye Disease