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(Reuters) -Alnylam Pharmaceuticals said on Monday it would not pursue expanded use of its drug to treat a potentially fatal heart disease in the U.S. after the Food and Drug Administration declined to approve the medication despite a favorable recommendation from its advisers. The regulator, in its so-called complete response letter, said the drug patisiran did not meaningfully improve the condition of patients with heart muscle issues or cardiomyopathy caused by ATTR amyloidosis, characterized ....
The FDA panel voted 9 to 3 that the benefits of the drug, patisiran, outweigh its risks for treating patients with a type of heart muscle disease, cardiomyopathy, caused by a wild-type or hereditary transthyretin-mediated amyloidosis (ATTR). ATTR, caused by mutations in the transthyretin gene, leads to accumulation of faulty proteins in body organs and tissues that can lead to loss of sensation, heart issues, eye, kidney and thyroid diseases. ....
This guide shares insights that help you to sharpen threat detection, allowing you to adopt and integrate any technology you need, all without sacrificing security. ....
Perceived wisdom goes that the way to outperform the market this year has been by leaning into the Magnificent Seven stocks (AAPL, AMZN, GOOGL, META, MSFT, NVDA, TSLA). These market leaders – all tech giants – are seen as being responsible for the market’s rally, but hold that thought, says Ark Invest CEO Cathie Wood. These names don’t take up much room in Wood’s flagship Ark Innovation ETF, yet the fund, with its focus on bold, innovative stocks, still managed to beat the main indexes’ performa ....