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ALNY / Alnylam to scrap sNDA for patisiran after receiving FDA complete response letter

Alnylam to scrap sNDA for patisiran after receiving FDA complete response letter
Alnylam Pharmaceuticals Inc. ALNY, -1.00% said Monday it would no longer pursue its supplemental new drug application (sNDA) for patisiran as a treatment for the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis after receiving a complete response letter from the U.S. Food and Drug Administration. Patisiran is already approved for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults. Read More
Posted: Oct 9 2023, 07:43
Author Name: Market Watch
Views: 112498

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Alnylam Stock Is Dropping on Surprising FDA Rejection

By Barrons
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Drugmaker Alnylam wanted to expand approval of its drug Onpattro, but the Food and Drug Administration rejected the application even after an outside more_horizontal

US FDA declines approval for expanded use of Alnylam's heart-disease drug

By Reuters
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Alnylam to scrap sNDA for patisiran after receiving FDA complete response letter

By Market Watch
October 9, 2023

Alnylam to scrap sNDA for patisiran after receiving FDA complete response letter

Alnylam Pharmaceuticals Inc. ALNY, -1.00% said Monday it would no longer pursue its supplemental new drug application (sNDA) for patisiran as a treatm more_horizontal


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