Recent FDA advisory committee meetings have dealt significant blows to GSK and Otsuka’s drug approval plans. GSK’s attempt to reintroduce its multiple myeloma antibody-drug conjugate Blenrep in combination regimens was rejected due to concerns about safety, dosing, and trial population demographics, particularly ocular toxicity and high rates of dose modifications observed in phase 3 studies. Simultaneously, the FDA’s Psychopharmacologic Drugs Advisory Committee voted overwhelmingly against approving Otsuka’s combination of Rexulti and Zoloft for post-traumatic stress disorder (PTSD), citing inconsistent efficacy data across multiple clinical trials. These advisory votes signal additional challenges ahead for both companies as they seek regulatory clearance to expand their treatment indications.