Surfactant replacement therapy (Surfaxin, Discovery Laboratories) for the prevention of respiratory distress syndrome (RDS) in premature infants
Approvable designations
Priority review
Fast-track designations
Nonapprovable designations
Recommendations against approval
FDA Approves Amvuttra for ATTR-CM in Extended Label
March 21st 2025This expanded indication for Amvuttra makes it the first and only FDA-approved treatment for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.
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