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.
Separately, the FDA also declined to approve Coherus BioSciences Inc and Chinese partner Shanghai Junshi Biosciences Co Ltd's cancer drug to treat a type of nasopharyngeal carcinoma, citing the need for quality process changes. Coherus and Shanghai Junshi plan to meet with the FDA and re-submit their application for the drug's approval by mid-summer 2022, the companies said.
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