Search Results for "Alnylam"
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Givosiran: Mechanism of Action and Chemical Properties
Standard response letter on the mechanism of action and chemical properties of givosiran.
Standard response letter on the mechanism of action and chemical properties of givosiran.
Patisiran: Technetium Uptake by Scintigraphy
Standard response letter on patisiran and technetium scintigraphy data assessed in a subset of patients from the APOLLO-B study.
Standard response letter on patisiran and technetium scintigraphy data assessed in a subset of patients from the APOLLO-B study.
Vutrisiran: Injection Site Reactions
Standard response letter on vutrisiran and injection site reactions.
Standard response letter on vutrisiran and injection site reactions.
Primary Results From APOLLO-B, A Phase 3 Study of Patisiran in Patients With Transthyretin-Mediated Amyloidosis With Cardiomyopathy
Alnylam Pharmaceuticals submitted a supplemental New Drug Application (sNDA) to the FDA for patisiran for the treatment of the cardiomyopathy of ATTR amyloidosis based on data from the APOLLO-B study. The FDA subsequently completed their review of the application in 2023 and issued a complete response letter (CRL).
Alnylam Pharmaceuticals submitted a supplemental New Drug Application (sNDA) to the FDA for patisiran for the treatment of the cardiomyopathy of ATTR amyloidosis based on data from the APOLLO-B study. The FDA subsequently completed their review of the application in 2023 and issued a complete response letter (CRL).
Vutrisiran: Concomitant Use with Tafamidis
Standard response letter on vutrisiran and concomitant use with tafamidis.
Standard response letter on vutrisiran and concomitant use with tafamidis.
Lumasiran: Pediatric Weight Based Dosing Increase Regimen
Standard response letter on lumasiran and protocol for dosing in pediatric patients who experience weight increases.
Standard response letter on lumasiran and protocol for dosing in pediatric patients who experience weight increases.
Vutrisiran Treatment in Patients with Transthyretin Amyloidosis with Cardiomyopathy
This asset represents the HELIOS-B primary results, published in the New England Journal of Medicine, in slide deck form.
This asset represents the HELIOS-B primary results, published in the New England Journal of Medicine, in slide deck form.
Givosiran: Latex Content
Standard response letter on the latex content of givosiran vial.
Standard response letter on the latex content of givosiran vial.
Lumasiran: Pregnancy and Lactation
Standard response letter on lumasiran and pregnancy and lactation in the Phase 2 OLE and Phase 3 ILLUMINATE studies.
Standard response letter on lumasiran and pregnancy and lactation in the Phase 2 OLE and Phase 3 ILLUMINATE studies.
