The FDA delayed approval of Bayer's non-hormonal menopause therapy elinzanetant by up to three months, citing additional review needs. Similarly, the EMA's Committee for Medicinal Products for Human Use (CHMP) declined Sarepta's Elevidys gene therapy, reaffirming safety concerns. In contrast, CHMP reversed course favorably on Eli Lilly's Alzheimer's drug Kisunla for select patients. The FDA also postponed decisions on GSK's Blenrep for multiple myeloma to further evaluate data amidst safety questions. These regulatory shifts highlight ongoing review complexities for critical therapeutics in various indications.