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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 ...
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 ...
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 ...
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 ...
Alnylam Pharma’s Regulatory Challenges and Market Uncertainty Lead to Hold Rating
Leerink Partners analyst Mani Foroohar has maintained their neutral stance on ALNY stock, giving a Hold rating on November 25.Don't Miss our ...
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 ...
PharmiWeb1mon
Global Vutrisiran Market Projected to Reach USD 2,087 Million by 2033 at a 12% CAGR
The global vutrisiran market, valued at USD 600 million in 2022, is expected to experience substantial growth, reaching an estimated USD 2,087 million by 2033, with a compound annual growth rate (CAGR ...
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 ...