The U.S. Food & Drug Administration (FDA) on Monday declined to approve two cancer treatment drugs developed by drugmakers who tested their products mainly in China.
The federal agency’s rejection is a sign of an increasingly tough U.S stance on drugs being tested solely in China, after some drugmakers moved to save costs by conducting clinical trials only in China.
The FDA sent Complete Response Letters (CRLs) to Hutchmed Inc. and Coherus BioSciences Inc. on Monday in response to the biotechnology companies’ New Drug Applications (NDAs) to sell their drugs in the U.S. market.
The rejection marks the second time the federal agency has rejected drugs tested in China this year.
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