Recent FDA advisory committee votes have rejected Otsuka's PTSD drug Rexulti-Zoloft combination after concerns about failed Phase 3 trials and safety issues. Concurrently, a panel urged the removal of warnings on hormone therapy for menopause, reflecting shifting perspectives under FDA Commissioner Martin Makary. Yet, GlaxoSmithKline faced FDA panel rejection for reinstating its multiple myeloma drug Blenrep citing toxicity and dosage concerns. These regulatory decisions underscore the ongoing debate on balancing efficacy and safety in drug approval processes.