pharmaphorum2d
Alnylam hails vutrisiran data, but investors seem sceptical
Alnylam Pharma has been riding high since revealing top-line results from its HELIOS-B trial of vutrisiran in transthyretin-mediated amyloidosis (ATTR) – but a look at the full data seems to ...
BioSpace5d
Days After BridgeBio Approval, FDA Agrees to Review Alnylam’s Amvuttra in ATTR-CM
The FDA has accepted Alnylam’s supplemental New Drug Application for Amvuttra on the heels of BridgeBio’s Attruby nod, ...
Monthly Prescribing Reference5d
Vutrisiran Under Review for Transthyretin Amyloid Cardiomyopathy
Vutrisiran, a transthyretin-directed small interfering RNA therapeutic, is currently approved under the brand name Amvuttra ® for the treatment of polyneuropathy manifestations of hereditary ...
Hosted on MSN5mon
Alnylam's Closely Watched Phase 3 Heart Disease Trial Of Vutrisiran Hits Primary Endpoint, Shares Surge
Monday, Alnylam Pharmaceuticals Inc (NASDAQ:ALNY) revealed topline results from its HELIOS-B Phase 3 study of vutrisiran, an investigational RNAi therapeutic in development for ATTR amyloidosis ...
Hosted on MSN4d
FDA Begins Review of Alnylam's sNDA for Expanded Amvuttra Use
Alnylam Pharmaceuticals ALNY announced that the FDA has accepted its supplemental new drug application (sNDA) seeking the ...
FDA accepts Alnylam’s sNDA for vutrisiran for ATTR-CM treatment
Pharmaceuticals announced that the U.S. Food and Drug Administration or FDA, has accepted for review the Company’s supplemental ...
Business Wire1mon
Alnylam Submits Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration for Vutrisiran for the Treatment of Transthyretin Amyloidosis with Cardiomyopathy
Vutrisiran is the generic name for AMVUTTRA ®, which is currently approved by the U.S. FDA for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults. As part of the ...
pharmaphorum4d
Alnylam’s vutrisiran aces ATTR cardiomyopathy readout
Alnylam is riding high today after reporting its RNAi drug vutrisiran showed across-the-board efficacy in cardiomyopathy associated with transthyretin-mediated amyloidosis (ATTR), setting up ...
Nasdaq5d
FDA accepts Alnylam’s sNDA for vutrisiran for ATTR-CM treatment
Alnylam (ALNY) Pharmaceuticals announced that the U.S. Food and Drug Administration or FDA, has accepted for review the Company’s supplemental New Drug Application sNDA for vutrisiran ...
Nasdaq1mon
Alnylam Submits Regulatory Application to the European Medicines Agency for Vutrisiran for the Treatment of ATTR Amyloidosis with Cardiomyopathy
− Type II Variation Submission Based on the Positive HELIOS-B Phase 3 Study in which Vutrisiran Significantly Reduced the Risk of Death and Cardiovascular Events Relative to Placebo – “Today ...
Business Wire1mon
Alnylam to Showcase Latest Data from TTR Franchise and Hypertension Program at American Heart Association Scientific Sessions 2024
Data presentations for the Company’s flagship TTR franchise include new findings from an analysis of the HELIOS-B Phase 3 study of vutrisiran, an RNAi therapeutic in development for the ...