The U.S. Food and Drug Administration has approved a drug developed at Stanford Medicine that offers hope to people diagnosed ...
Acoramidis has been cleared under the Attruby brand name as an oral therapy to reduce cardiovascular death and cardiovascular-related hospitalisation in adults with ATTR-CM, a progressive disease ...
Although head-to-head results on tolerability were missing from the company’s data release, Eli Lilly and Co. said its U.S. FDA-approved weight-loss drug Zepbound (tirzepatide) beat the also-cleared ...
Beacon Biosignals Inc. can rest easy now that it has received U.S. FDA authorization of its predetermined change control plan ...
This week, the FDA issued recommendations for streamlining the clearance process for AI-powered medical devices. The memo announcing this change recognizes that the utilization of AI in devices “is an ...
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The drug, known scientifically as acoramidis, will be sold by BridgeBio under the brand name Attruby. The FDA cleared Attruby to treat patients with the heart condition known as transthyretin ...
Among important regulatory news last week, US drugmaker BridgeBio Pharma gained Food and Drug Administration (FDA) approval ...
11/23
11/23,FDA 批准 BridgeBio Pharma $BridgeBio Pharma(BBIO)$ 的 Attruby (acoramidis) 用于降低转甲状腺素蛋白淀粉样心肌病 (ATTR-CM) 患者的心血管死亡和心血管相关住院率,与辉瑞的 tafamidis 展开直接竞争,后者具有相同的作用机制,但批准的适应症更有限。 Attruby 是一种口服 TTR 稳定剂,FDA的批准称该 ...
Congratulations! Also, I like BridgeBio’s approach to honor the courage of the clinical trial participants and provide these patients Attruby free for life. This could change future industry ...