The US FDA announces the approval of two IND applications, as well as for bevacizumab-nwgd. Read more
China’s NMPA accepts a marketing authorization application for foritinib following interim results from the phase III REMARK trial. Read more
The drug’s developers have said the data show a positive overall response rate in previously treated patients with NSCLC with EGFR exon 20 insertion mutations. Read more
Though the study is small, the sponsor says results are promising for the first-in-class telomere-targeting agent. Read more
Data from the Beamion LUNG-1 trial show a 71% objective response rate in previously treated patients. Read more
Durvalumab is recommended for approval in the EU, Health Canada approves pembrolizumab, and the US FDA grants priority review to datopotamab deruxtecan. Read more
Dr. Susan Scott discusses how findings from the MARIPOSA and FLAURA-2 trials will be incorporated into clinical practice. Read more
The US FDA grants fast track designation to treat KRAS G12C-mutant metastatic NSCLC and China’s NMPA approves taletrectinib for advanced ROS1-positive NSCLC. Read more
FDA issues draft guidance on the use of AI for biological and drug product submissions, China’s NMPA grants priority review for the combination of savolitinib and osimertinib, and nivolumab and hyaluronidase-nvhy receive FDA approval for subcutaneous injection. Read more
The US FDA approves ensartinib for ALK-positive NSCLC and provides an updated regulatory review of subcutaneous amivantamab. Read more