US FDA approves the PD-1 inhibitor 20 months after user fee goal, resolving one of the last applications delayed by China’s extended pandemic travel restrictions.
The US FDA’s approval of BeiGene, Ltd.’s PD-1 inhibitor Tevimbra (tislelizumab-jsgr) removes one of the last novel agent applications delayed by COVID-19 from the agency’s review queue.
The 13 March 2024 approval came 20 months after Tevimbra’s 12 July 2022 standard review user fee goal for treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after
The Tevimbra approval clears out the backlog of COVID-delayed novel agent applications
Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.
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Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.
