Recent FDA action (through October 2008) related to vernakalant, doripenem, custirsen, droxidopa, amrubicin, dronedarone, and imatinib.
Approvable designation*
Complete responses*
Fast-track designations
Orphan drug designations
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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