FDA Commissioner Margaret Hamburg was asked if the fungal meningitis outbreak could have been prevented by FDA during a 4-hour hearing Nov. 14 headed by the chairman of the House Energy and Commerce oversight subcommittee. Her answer was that FDA had limited authority because the New England Compounding Center (NECC), Framingham, Mass., was a ?compounding pharmacy,? which is regulated by the state Board of Pharmacy.
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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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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