Search Results for "Alnylam"
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For more information about our FDA-approved therapies, please see the Full Prescribing Information:
Phase 3 HELIOS-B Study Rationale
This slide deck highlights the Phase 3 trial design for HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy.
This slide deck highlights the Phase 3 trial design for HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy.
Givosiran: Elevations in Blood Homocysteine
Standard response letter on givosiran and elevations in blood homocysteine.
Standard response letter on givosiran and elevations in blood homocysteine.
Patisiran: Observation Period After Infusion
Standard Response Letter on the observational period after patisiran infusion in the APOLLO, APOLLO-B, Global OLE, and HELIOS‑A studies.
Standard Response Letter on the observational period after patisiran infusion in the APOLLO, APOLLO-B, Global OLE, and HELIOS‑A studies.
Patisiran: Temperature Excursions
Standard response letter on patisiran and temperature excursions. The letter includes information on the impact of temperature excursions not lower than -4°C and up to 40°C on the stability of patisiran.
Standard response letter on patisiran and temperature excursions. The letter includes information on the impact of temperature excursions not lower than -4°C and up to 40°C on the stability of patisiran.
Zilebesiran: KARDIA-1 Study
Standard response letter on zilebesiran and the KARDIA-1 study, an ongoing phase 2 study evaluating the efficacy and safety of zilebesiran dosing regimens for adults with mild to moderate hypertension.
Standard response letter on zilebesiran and the KARDIA-1 study, an ongoing phase 2 study evaluating the efficacy and safety of zilebesiran dosing regimens for adults with mild to moderate hypertension.
Patisiran: Dose Ranging Studies
Standard response letter on patisiran phase 1 and phase 2 dose ranging studies.
Standard response letter on patisiran phase 1 and phase 2 dose ranging studies.