The ATTRibute-CM Phase III trial, which formed the basis for the FDA’s approval, enrolled 632 subjects with symptomatic ATTR-CM. Credit: Theerani lerdsri/Shutterstock. The US Food and Drug ...
We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. The FDA approved a new 160 cm endovascular navigation ...
CAMBRIDGE, Mass., March 20, 2025--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the U.S. Food and Drug Administration (FDA) ...
Alnylam (ALNY) Pharmaceuticals announced that the U.S. Food and Drug Administration or FDA, has accepted for review the Company’s supplemental New Drug Application sNDA for vutrisiran, an ...
On Friday, the FDA approved BridgeBio Pharma, Inc.’s (NASDAQ:BBIO) Attruby (acoramidis), an orally-administered near-complete (≥90%) stabilizer of Transthyretin (TTR) for adults with ATTR-CM to reduce ...
PALO ALTO, Calif., Feb. 05, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and ...
This expanded indication for Amvuttra makes it the first and only FDA-approved treatment for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and the polyneuropathy of hereditary ...
BridgeBio (BBIO) Pharma announced that the U.S. Food and Drug Administration approved Attruby, an orally-administered near-complete stabilizer of Transthyretin, or TTR, for the treatment of adults ...
In a clinical trial, vutrisiran was superior to placebo in reducing cardiovascular events and all-cause mortality in patients with ATTR-CM. The US Food and Drug Administration (FDA) has approved ...
The agency’s briefing document found Phase III results investigating patisiran’s effects versus placebo were “small, of questionable clinical meaningfulness, and may not be detectable by patients.” ...
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