Search Results for "Alnylam"
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For more information about our FDA-approved therapies, please see the Full Prescribing Information:
Givosiran: Pregnancy and Lactation
Standard response letter on givosiran and its use in pregnant or lactating patients.
Standard response letter on givosiran and its use in pregnant or lactating patients.
Efficacy and Safety of Vutrisiran and Patisiran
Standard response letter on the efficacy and safety of vutrisiran and patisiran, summarizing data from the HELIOS-A study and the APOLLO study.
Standard response letter on the efficacy and safety of vutrisiran and patisiran, summarizing data from the HELIOS-A study and the APOLLO study.
Givosiran: Use in Pediatric Patients
Standard response letter on givosiran and pediatric use. This medical information response contains clinical data from the ENVISION study, ELEVATE registry, and published case reports.
Standard response letter on givosiran and pediatric use. This medical information response contains clinical data from the ENVISION study, ELEVATE registry, and published case reports.
Patisiran: Transitioning from Inotersen
Standard response letter on transitioning from an antisense oligonucleotide to patisiran.
Standard response letter on transitioning from an antisense oligonucleotide to patisiran.
Patisiran: Compatibility with Commonly Used Infusion Components
Standard response letter on patisiran and compatibility with commonly used infusion components based on a compatibility and stability study.
Standard response letter on patisiran and compatibility with commonly used infusion components based on a compatibility and stability study.
Vutrisiran: Cardiac Results from the HELIOS-A Study
Standard response letter on vutrisiran and exploratory cardiac results from the HELIOS-A study evaluating efficacy and safety of vutrisiran in patients with polyneuropathy of hATTR.
Standard response letter on vutrisiran and exploratory cardiac results from the HELIOS-A study evaluating efficacy and safety of vutrisiran in patients with polyneuropathy of hATTR.
Patisiran: Liver Function Tests
Standard response letter on patisiran and liver function tests in the APOLLO study and pooled population from the phase 2 study, APOLLO, APOLLO-B, and OLE studies.
Standard response letter on patisiran and liver function tests in the APOLLO study and pooled population from the phase 2 study, APOLLO, APOLLO-B, and OLE studies.
Patisiran: Dosing Schedule
Standard response letter on patisiran and the dosing schedule used in clinical trials.
Standard response letter on patisiran and the dosing schedule used in clinical trials.
Lumasiran: Clinical Pharmacology
Standard Response Letter on lumasiran and its pharmacokinetic and pharmacodynamic properties.
Standard Response Letter on lumasiran and its pharmacokinetic and pharmacodynamic properties.
Vutrisiran: Cross-Reactivity with Patisiran
Standard response letter on the cross-reactivity between vutrisiran and patisiran.
Standard response letter on the cross-reactivity between vutrisiran and patisiran.
