Several biopharmaceutical companies are navigating ongoing regulatory challenges and approvals. GSK’s antibody-drug conjugate Blenrep, targeting multiple myeloma, faces continued FDA review delays amid safety and dosing concerns, pushing a final decision to October. Bayer’s nonhormonal menopause therapy, elinzanetant, is undergoing extended FDA evaluation despite prior regulatory approvals in Europe and Canada. Meanwhile, the FDA is developing new influenza vaccine frameworks addressing efficacy and strain selection issues. The European Medicines Agency’s CHMP supported several orphan drug approvals, including Lilly’s Alzheimer’s therapy Kisunla for selected patient populations, reversing earlier negative recommendations. These regulatory dynamics highlight the evolving landscape and nuanced decision-making in drug approvals this year.