FDA has approved osimertinib, developed by AstraZeneca, for the treatment of adult patients with locally advanced, unresectable stage III non-small cell lung cancer (NSCLC) with EGFR mutations. The approval was based on efficacy data from the LAURA phase 3 trial, which demonstrated promising results in NSCLC patients who had not progressed after platinum-based chemoradiation. The […]...
FDA Approves Keytruda Pembrolizumab +Chemotherapy...
FDA has approved pembrolizumab marketed as Keytruda by Merck in…
FDA Lifts Partial Clinical Hold...
FDA has lifted the partial clinical hold on studies investigating…
FDA Clears Vironexis IND-VNX-101 for...
FDA has cleared Vironexis Biotherapeutics Investigational New Drug (IND) application…