Drugs.com FDA MedWatch AlertsOriginal article
FDA Takes Action on New Boxed Warning for Adzynma Enzyme Replacement Therapy for Congenital Thrombotic Thrombocytopenic Purpura (cTTP)
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Summary
The FDA issued a new boxed warning for Adzynma (recombinant ADAMTS13), an enzyme replacement therapy approved for congenital thrombotic thrombocytopenic purpura. The alert was directed at patients, caregivers, and healthcare providers on September 23, 2026.
Outcome Details
FDA issued new boxed warning
Importance:5/10
Sentiment:
-0.30
boxed warningsafety alertenzyme replacement therapyrare disease
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Published by Drugs.com FDA MedWatch Alerts on September 23, 2026 5:58 PM