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FDA

Regulatory intelligence
FDAsafety guidance72% confidence

Condition-Specific Meeting Reports and Other Information Related to Patients' Experience

Source: FDA

Why This Matters

Why this matters: sets a safety guidance precedent in the same sub-indication (cardiology) as Anthos Therapeutics.

Regulatory Analysis

This webpage provides links to certain publicly available external reports and resources relating to patient experience data. The patient community, patient advocates, researchers, drug developers, and federal agencies may find these materials useful.

Supporting Context

Therapeutic area
Cardiology · Atrial Fibrillation
Sub-indication
Hypertension

Related signal: Anthos and Novartis initiate LILAC-TIMI 76 trial for abelacimab in high-risk AF patients

Source

View source document

Related Signal

Open signal — Anthos and Novartis initiate LILAC-TIMI 76 trial for abelacimab in high-risk AF patients
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