FDA advisory committees have issued negative votes on notable drug candidates. Otsuka’s combination treatment of Rexulti and Zoloft for PTSD failed to demonstrate convincing efficacy in phase 3 trials and was voted down 10-1 by the Psychopharmacologic Drugs Advisory Committee. Separately, GSK’s multiple myeloma antibody-drug conjugate Blenrep faced strong FDA concerns over ocular toxicities and dosage optimization in phase 3 DREAMM trials, resulting in negative votes for proposed combinations. These setbacks underscore regulatory challenges in advancing treatments amid safety and efficacy scrutiny.