Ascendis Pharma Bone's Yorvipath gets labeling supplement approved by FDA
FDA approved a labeling supplement for Yorvipath (palopegteriparatide), covering three subcutaneous solution strengths for the sponsor Ascendis Pharma Bone.
A single regulatory update on Yorvipath this week.
- FDA approved supplement 11 to the New Drug Application for YORVIPATH, a subcutaneous solution containing palopegteriparatide, sponsored by Ascendis Pharma Bone1. The submission was classified as a labeling supplement, with the approval letter dated August 6, 2026 and an updated label and medication guide posted August 11, 2026, per the application docs listed in the record.
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