FDA Criticizes Bristol Myers Squibb for Misleading Efficacy Claims on Krazati Website

Bristol Myers Squibb, FDA, Krazati, misleading efficacy claims, non-small-cell lung cancer, NSCLC, KRAS G12C-mutated, cancer treatment

BMS Details Confirmatory Trial Win for KRAS Inhibitor Krazati

Bristol Myers Squibb, Krazati, KRAS inhibitor, confirmatory trial, non-small cell lung cancer (NSCLC), progression-free survival (PFS), chemotherapy, accelerated approval, FDA

Bristol Myers Squibb’s KRAZATI Confirmed Effective in Pivotal Phase 3 KRYSTAL-12 Trial Following Accelerated Approval

Bristol Myers Squibb, KRAZATI (adagrasib), Pivotal Phase 3 trial, KRYSTAL-12 study, Primary endpoint met, Progression-free survival (PFS), Overall response rate (ORR), Confirmatory trial, Non-small cell lung cancer (NSCLC), Locally advanced or metastatic, KRASG12C mutation, Accelerated approval, Continued approval contingent on clinical benefit verification, FDA assigned PDUFA goal date of June 21/ 2024