Search Results for "Alnylam"
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For more information about our FDA-approved therapies, please see the Full Prescribing Information:
Mivelsiran: cAPPricorn-1 Study
Standard response letter on mivelsiran and the phase 2 cAPPricorn-1 study in patients with sporadic or hereditary CAA.
Standard response letter on mivelsiran and the phase 2 cAPPricorn-1 study in patients with sporadic or hereditary CAA.
Patisiran: Cardiac Results from the APOLLO Study
Standard response letter on patisiran and the exploratory cardiac results in the APOLLO study, a study evaluating the efficacy and safety of patisiran in patients with the polyneuropathy of hATTR.
Standard response letter on patisiran and the exploratory cardiac results in the APOLLO study, a study evaluating the efficacy and safety of patisiran in patients with the polyneuropathy of hATTR.
Givosiran: Renal Effects
Standard response letter on renal effects observed with the use of givosiran.
Standard response letter on renal effects observed with the use of givosiran.
Transition between Patisiran and Vutrisiran
Standard response letter on transitioning between patisiran and vutrisiran therapy.
Standard response letter on transitioning between patisiran and vutrisiran therapy.
Vutrisiran: Post-Orthotopic Liver Transplant
Standard response letter on the exclusion of patients with a history of liver transplant from the HELIOS studies of vutrisiran.
Standard response letter on the exclusion of patients with a history of liver transplant from the HELIOS studies of vutrisiran.
Vutrisiran: Use in Patients Undergoing Dialysis
Standard response letter on the use of vutrisiran in patients undergoing dialysis.
Standard response letter on the use of vutrisiran in patients undergoing dialysis.
Givosiran: CYP Enzyme Interactions
Standard response letter on CYP enzyme drug-drug interactions with givosiran.
Standard response letter on CYP enzyme drug-drug interactions with givosiran.
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.
