Managed Healthcare Executive14d
FDA Accepts sNDA ATTR Amyloidosis Drug, Vutrisiran
Vutrisiran is the generic form of previously approved Amvuttra. The FDA’s target date for the treatment of transthyretin ...
Hosted on MSN14d
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 ...
BioSpace15d
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, ...
pharmaphorum4d
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 ...
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 ...
Monthly Prescribing Reference15d
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 ...
pharmaphorum5mon
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 ...
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 Insider1mon
Alnylam Pharma: Buy Rating Affirmed on Strong Vutrisiran Potential and Favorable ICER Review
The recent report from the Institute for Clinical and Economic Review (ICER) has shown a higher confidence in the effectiveness of vutrisiran, a drug developed by Alnylam, compared to traditional ...
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 ...
Nasdaq15d
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 ...
Yahoo Finance14d
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 label expansion of Amvuttra (vutrisiran) for review to treat ATTR ...