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BeiGene: FDA Defers Action On BLA For Tislelizumab Due To Travel Restrictions

BeiGene (BGNE) announced the FDA has deferred action on the Biologics License Application for tislelizumab as a second-line treatment for patients with unresectable or metastatic esophageal squamous cell carcinoma. The FDA is deferring action on the application as it has been unable to conduct required inspections in China due to COVID-19 related travel restrictions. In September 2021, the FDA accepted the BLA for tislelizumab and provided a PDUFA goal date of July 12, 2022.

BeiGene and Novartis will continue to work with the FDA to support scheduling the required inspections as soon as possible.

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