Search Results for "Alnylam"
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For more information about our FDA-approved therapies, please see the Full Prescribing Information:
Lumasiran: Temperature Cycling and Stability
Standard response letter on the temperature cycling and stability of lumasiran. This letter contains stability data assessed from a batch of lumasiran drug product stored under long term conditions and thermal and cyclic stress.
Standard response letter on the temperature cycling and stability of lumasiran. This letter contains stability data assessed from a batch of lumasiran drug product stored under long term conditions and thermal and cyclic stress.
Lumasiran: Latex Content
Standard response letter on the latex content of lumasiran vial.
Standard response letter on the latex content of lumasiran vial.
Patisiran: Ocular Adverse Events
Standard response letter on patisiran and ocular adverse events in the APOLLO study.
Standard response letter on patisiran and ocular adverse events in the APOLLO study.
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: 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: 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.
Lumasiran: ILLUMINATE-C Study Overview
Standard response letter on lumasiran phase 3 clinical study ILLUMINATE-C, a study evaluated the efficacy and safety of lumasiran in infants to adult patients with PH1 and advanced kidney disease.
Standard response letter on lumasiran phase 3 clinical study ILLUMINATE-C, a study evaluated the efficacy and safety of lumasiran in infants to adult patients with PH1 and advanced kidney disease.
