Published 2 years ago

U.S. FDA declines to approve two more China-tested drugs

Summary by Ground News

The FDA declined to approve two China-tested cancer treatments on Monday. The decisions could add pressure on Chinese stocks, especially biotech companies. There are at least 25 applications from China in drug development phases that are predominantly or solely based on trial data from China, the FDA said in February.

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Reuters

U.S. FDA declines to approve two more China-tested drugs

The U.S. Food & Drug Administration declined to approve two China-tested cancer treatments on Monday, saying one of the companies - Hutchmed Ltd - needs to test its drug for the U.S. population in a diverse multi-regional trial.

2 years ago·United Kingdom

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Channel News Asia

US FDA declines to approve two more China-tested drugs

The US Food & Drug Administration declined to approve two China-tested cancer treatments on Monday, raising concerns over the future of drugs tested in single-country trials. The decisions could add pressure on Chinese stocks, especially biotech companies, at a time shares of several US-listed Chi

2 years ago·Singapore

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National Post

U.S. FDA declines to approve Hutchmed's China-tested cancer drug

The U.S. Food and Drug Administration has declined to approve a cancer drug developed by Hutchmed Ltd , the China-based drugmaker said on Monday, handing yet another blow to treatments tested mainly in China. Read More

2 years ago·Canada

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Financial Post

U.S. FDA declines to approve Hutchmed's China-tested cancer drug

Drugmaker Hutchmed Ltd said on Monday the U.S. Food and Drug Administration has declined to approve its cancer drug which was tested mainly in China, citing the need for a multi-regional clinical trial. Read More

2 years ago·Canada

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大纪元 www.epochtimes.com

US FDA refuses to approve three types of cancer drugs tested in China

[Epoch May 02, 2022 News] (Epoch Times reporter Li Yan Comprehensive Report) The US Food and Drug Administration (FDA) once again refused to approve a type of cancer drug that is mainly overtested in China on Monday (May 2). This is the third time in more than a month that the organization has rejected a drug developed in China. Hutchison Whampoa (Hutchison Whampoa, Hutchison Whampoa) has issued a “Complete Response Letter” (Complete Response Le…

2 years ago

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Times Live

Hutchmed's China-tested cancer drug fails to get US approval

Hutchmed Ltd said on Monday the US Food and Drug Administration has declined to approve its cancer drug, citing the need for a multi-regional clinical trial, becoming the second China-tested drug to be rejected by the US regulator this year.

2 years ago·Johannesburg, South Africa

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