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.

For More Such Health News, visit rttnews.com.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
American Honda Motor Co, Inc. has recalled about 2,900 units of 2022 model year Honda TRX90X All-Terrain Vehicles (ATVs) sold in the United States for possible crash and injury hazard, according to a statement issued by the U.S. Consumer Product Safety Commission or CPSC. The Laundress, a unit of Conopco Inc. d/b/a Unilever, is recalling around 8 million laundry and household cleaning products citing risk of exposure to bacteria, U.S. Consumer Product Safety Commission. The recall involves Laundress laundry detergent, fabric conditioner and other cleaning products. Tesla Inc. has delivered its first Semi, a heavy-duty electric truck, to its customer PepsiCo Inc. during an event at its Nevada Gigafactory. The delivery of 500-mile fully electric Semi truck comes five years after the launch of the truck's prototype in 2017. During Thursday night's Semi Delivery Event at Tesla's Sparks, Nevada factory, CEO Elon Musk, with Dan Priestly, ...
Follow RTT