Two decisions by the US Food and Drug Administration in recent months have got me thinking about how to balance the need for evidentiary rigor with the need for regulatory flexibility enabling timely ...
The RNA interference (RNAi) therapeutic, patisiran (Onpattro; Alnylam), showed a statistically significant and clinically meaningful benefit on functional capacity, as measured by the 6-minute walk ...
According to new research, patisiran maintains long-term kidney function in ATTR-PN. Long-term patisiran treatment maintained stable eGFR in patients with ATTR-PN and chronic kidney disease, ...
Alnylam has presented a fresh take on its phase 3 patisiran data as it builds out its case ahead of an anticipated landmark approval. The new angle comes from an exploratory post hoc analysis which ...
Please provide your email address to receive an email when new articles are posted on . In patients with transthyretin-mediated amyloidosis with cardiomyopathy, patisiran improved functional capacity ...
For patients with transthyretin amyloidosis (ATTR amyloidosis), administration of an RNA interference therapeutic agent, patisiran, over 12 months results in preserved functional capacity, according ...
Alnylam Pharmaceuticals Inc ALNY released new results from an interim analysis of exploratory data from the open-label extension (OLE) period of the APOLLO-B Phase 3 study of patisiran, for the ...
A group of advisers to the Food and Drug Administration voted in favor of Alnylam Pharmaceuticals’ treatment for a debilitating heart disease Wednesday, but only after a day-long debate challenging ...
LOS ANGELES — Results of a new study show encouraging results with patisiran (Alnylam Pharmaceuticals), an investigational agent for the treatment of hereditary ATTR (hATTR) amyloidosis, in improving ...
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that it has made substantial progress in the global ...
Alnylam has stepped up its commitment to pioneering RNAi drug patisiran by retooling its agreement with Sanofi. The revised deal returns full global control of the ATTR amyloidosis drug to Alnylam and ...
(RTTNews) - Alnylam Pharmaceuticals, Inc. (ALNY) announced the FDA has issued a Complete Response Letter in response to the company's supplemental New Drug Application for patisiran for the treatment ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results