Regulatory agencies continue to navigate complex reviews amid novel therapies and market dynamics. The FDA has extended its review of Bayer’s non-hormonal menopause drug elinzanetant by up to three months, with Canada and the UK already having approved the therapy. The FDA also granted breakthrough device designation to Cryofocus for a cryoablation system targeting asthma, triggering a notable surge in the company's stock. The European Medicines Agency’s CHMP recommended approval for Lilly’s Alzheimer’s drug Kisunla in select patients, reversing an earlier rejection. Additionally, Roche obtained CE marking for the Elecsys pTau181 test aiding Alzheimer’s rule-out diagnostics. Meanwhile, the FDA approved LEO Pharma’s topical cream Anzupgo as the first treatment for chronic hand eczema in the U.S. These decisions highlight a regulatory landscape balancing innovation with safety and efficacy requirements.