The FDA, which has taken a tougher stance on China-developed drugs, postponed a decision on one from Novartis and BeiGene for esophageal cancer because staff hadn’t completed required inspections in China
The Food and Drug Administration delayed a decision on a proposed new esophageal-cancer treatment from Novartis AG and BeiGene Ltd.
until the agency can complete inspections in China that have been delayed byThe drug, tislelizumab, was initially developed by BeiGene, a company with Chinese operations that is incorporated in the Cayman Islands. BeiGene first tested the drug in cancer patients in China, and the company has manufacturing operations there.
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