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 ...

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 ...

Beacon Biosignals Inc. can rest easy now that it has received U.S. FDA authorization of its predetermined change control plan ...

The U.S. Food and Drug Administration has approved a drug developed at Stanford Medicine that offers hope to people diagnosed ...

If granted, Tremfya will be approved to treat children ages six and under with severe plaque psoriasis and children ages five ...

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 ...

Among important regulatory news last week, US drugmaker BridgeBio Pharma gained Food and Drug Administration (FDA) approval ...

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See the new treatment that will break a Pfizer monopoly on a drug for heart disease.

Kronos is cutting 83% of its workforce, while Idorsia is considering eliminating as many as 270 jobs. Elsewhere, PTC ...

BridgeBio’s Attruby wins approval for transthyretin amyloid cardiomyopathy while the FDA accepts Alnylam’s application for ...

New guidance from health technology assessment (HTA) agency NICE backs the use of Wainzua (eplontersen) to treat stage 1 or 2 ...