FDA Approval

Alnylam Announces Receipt of Complete Response Letter from U.S. FDA for Supplemental New Drug Application for Patisiran for the Treatment of the Cardiomyopathy of ATTR Amyloidosis

Published: Oct 09, 2023 - FDA Cites Insufficient Evidence of Clinical Meaningfulness - - No Clinical Safety, Study Conduct, Drug Quality or Manufacturing…

Alnylam Announces FDA Approval of AMVUTTRA™ (Vutrisiran), an RNAi Therapeutic for the Treatment of the Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis in Adults

Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, announced that the U.S. Food and Drug Administration (FDA) approved AMVUTTRA(tm) (vutrisiran…

U.S. FDA Approves VYNDAQEL® and VYNDAMAX™ for Use in Patients with Transthyretin Amyloid Cardiomyopathy, a Rare and Fatal Disease

Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved both VYNDAQEL(R) (tafamidis meglumine) and VYNDAMAX(tm) (tafamidis) for…

FDA Approves Alnylam’s Onpattro for Polyneuropathy of hATTR Amyloidosis

FDA OKs Inotersen (Tegsedi) for Hereditary ATTR With Polyneuropathy

Inotersen: An Exciting Prospect for hATTR Amyloidosis Treatment

FDA Approves Patisiran Infusion for Hereditary Transthyretin-Mediated Amyloidosis

The FDA announced that it has approved patisiran infusion for the treatment of patients with peripheral nerve disease caused by hereditary transthyretin-mediated…

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