Search Results for "Alnylam"
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For more information about our FDA-approved therapies, please see the Full Prescribing Information:
Lumasiran: Latex Content
Standard response letter on the latex content of lumasiran vial.
Standard response letter on the latex content of lumasiran vial.
Givosiran: Pancreatitis
Standard response letter on givosiran and the adverse event of pancreatitis.
Standard response letter on givosiran and the adverse event of pancreatitis.
Givosiran: Temperature Excursions
Standard response letter on givosiran and temperature excursions. This letter contains information on product stability when stored under long-term and accelerated conditions.
Standard response letter on givosiran and temperature excursions. This letter contains information on product stability when stored under long-term and accelerated conditions.
Vutrisiran: Cardiac Biomarkers in HELIOS-B
Standard response letter on exploratory cardiac biomarker analyses in HELIOS-B.
Standard response letter on exploratory cardiac biomarker analyses in HELIOS-B.
Vutrisiran: HELIOS-A Study
Standard response letter on vutrisiran and results from the HELIOS-A study evaluating efficacy and safety of vutrisiran in patients with the polyneuropathy of hATTR.
Standard response letter on vutrisiran and results from the HELIOS-A study evaluating efficacy and safety of vutrisiran in patients with the polyneuropathy of hATTR.
Patisiran: Post-Orthotopic Liver Transplant
Standard response letter on patisiran and the open-label phase 3 study evaluating the efficacy, safety and PK of patisiran in patients with hATTR who had polyneuropathy progression post-OLT. Additional summaries of case reports are also included.
Standard response letter on patisiran and the open-label phase 3 study evaluating the efficacy, safety and PK of patisiran in patients with hATTR who had polyneuropathy progression post-OLT. Additional summaries of case reports are also included.
Vutrisiran: Concomitant Use with Diflunisal
Standard response letter on the use of vutrisiran with concomitant diflunisal.
Standard response letter on the use of vutrisiran with concomitant diflunisal.
Vutrisiran: Post-Hoc Analysis of HELIOS-A Results by Baseline NIS Quartile
Standard response letter summarizing the results of a post-hoc analysis of the HELIOS-A study, conducted to evaluate the impact of baseline polyneuropathy severity, as measured by NIS, on response to vutrisiran treatment.
Standard response letter summarizing the results of a post-hoc analysis of the HELIOS-A study, conducted to evaluate the impact of baseline polyneuropathy severity, as measured by NIS, on response to vutrisiran treatment.
