The combination of the antibody amivantamab and lazertinib, a drug targeting EGFR, shows better clinical benefits compared to standard treatment in patients with advanced or metastatic non-small cell lung cancer with EGFR gene mutations who also present one of these poor prognosti markers: brain and/or liver metastases, p53 gene co-mutations, or the presence of circulating tumor DNA.
AGC Biologics hit with 483 for poor discrepancy investigation practices, quality control issues at Washington site
CDMO ACG Biologics received an FDA 483 letter, published on the FDA website this week, noting one of its sites failed to conduct proper investigations
February 2, 2024