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STAT News· Adam Feuerstein·· 2 小时前AI 评分58

Vertex 肾病药物因感染风险在 FDA 审批前受审视

STAT+: Vertex kidney disease drug scrutinized for infection risk

AI 导读

Vertex 一款肾病药物在 FDA 审批决定前因感染风险受到审视,一项此前未披露的暂停规则引发对其标签内容的疑问。该药被普遍预期将获得 FDA 批准,相关讨论出现在美国肾脏病学会年会期间。

正文 · 原文

Vertex’s drug is widely expected to secure FDA approval, but a previously undisclosed pause rule has raised questions about the drug’s label

Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast The Readout Loud and author of the newsletter Adam’s Biotech Scorecard. You can reach Adam on Signal at stataf.54.

This is the online version of Adam’s Biotech Scorecard, a weekly newsletter featuring exclusive, spicy analysis on the biotech industry. Sign up here to get it delivered to your inbox.

Spain is amazing. I was in Madrid for five days covering the ESMO conference. Now, I’m delivering this newsletter to you from a balcony overlooking the Mediterranean.

Vertex kidney disease drug scrutinized for infection risk ahead of FDA approval decision

Adam Feuerstein/STAT

So many medical meetings, so little time. While I was in Madrid reporting on cancer drugs, kidney disease specialists and the investors and analysts who tag along were in Denver for the annual meeting of the American Society of Nephrology.

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  1. Senior Writer, Biotech

    Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast The Readout Loud and author of the newsletter Adam’s Biotech Scorecard. You can reach Adam on Signal at stataf.54.

来源:STAT News · statnews.com

AI 摘要声明:站内标题、摘要与推荐理由由模型基于公开来源生成,属机器生成内容,非原文;本页内容仅供医药行业信息参考,不构成医疗建议、诊断或用药依据。