Drug Approval | August 12, 2025
Boehringer’s lung cancer medicine gets FDA approval
FDA grants accelerated approval to zongertinib for HER2 TKD-Mutated Non-Squamous NSCLC
FDA grants accelerated approval to zongertinib for HER2 TKD-Mutated Non-Squamous NSCLC
Innovative plate-based internalization reagents designed to deliver accurate, high-throughput, and scalable insights for GPCR and ADC research
The expansion will bring together talent in AI, data science, and engineering to build the digital foundation needed to accelerate drug discovery and delivery
His experience includes leadership roles in manufacturing, strategic management, and commercial operations across the pharmaceuticals, healthcare, and specialty chemicals sectors
First and only TROP2-directed therapy approved in the US for the treatment of lung cancer
The GMP-compliant facility with automated environmental monitoring accommodates both white room and class 7 and 8 cleanroom space
This project builds on a previous joint funding agreement between CARBOGEN AMCIS and the same customer in April 2021
First pivotal Phase 3 trial to show superiority of Keytruda plus a TROP2 antibody-drug conjugate, Trodelvy, versus standard of care in first-line metastatic TNBC
The decision to withdraw the BLA is based on topline overall survival (OS) results from the confirmatory HERTHENA-Lung02 Phase 3 trial where OS did not meet statistical significance
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