Oct 30, 2025 · FDA’s role in a recall is to oversee a company’s recall strategy and ensure adequate steps were taken to implement the recall. FDA evaluates the effectiveness of a recall …

Oct 12, 2023 · The recent and (mostly) surprise FDA rejection of Alnylam Pharmaceuticals’ RNAi drug Onpattro for patients with a rare genetic heart condition was a knock to the company’s …

Oct 9, 2023 · Alnylam has abandoned plans to add cardiomyopathy to the label for transthyretin-mediated amyloidosis (ATTR) therapy Onpattro after the FDA turned down its marketing …

Patisiran, sold under the brand name Onpattro, is a medication used for the treatment of polyneuropathy in people with hereditary transthyretin-mediated amyloidosis, [7] a fatal rare …

Oct 9, 2023 · Alnylam Pharmaceuticals will no longer seek expanded approval of Onpattro (patisiran) in the US for the treatment for cardiomyopathy of transthyretin-mediated …

(recalls are within these reports - you may also find other items)

Visit Drug recall information for consumers, health care professionals and industry for more information. Visit Recalls, Market Withdrawals, & Safety Alerts for all FDA-regulated products.

Dec 26, 2023 · This page also contains information that FDA gathers from company press releases and other public notices about certain recalls of FDA-regulated products.

The benefits and side effects of ONPATTRO were evaluated in one clinical trial. The trial enrolled patients who had hereditary transthyretin-mediated amyloidosis.

Sep 13, 2023 · One placebo patient stopped study participation during the DB period and died after the pre-specified window for the statistical analysis of deaths during the DB period. …