The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recently issued several decisions, approving five orphan drugs including Eli Lilly’s Alzheimer’s therapy Kisunla for early-stage patients who are ApoE4 heterozygotes or non-carriers. This reverses the earlier rejection of Kisunla due to brain swelling risks. Gilead’s twice-yearly HIV prevention shot also gained CHMP backing. These regulatory shifts reflect nuanced evaluations of benefit-risk profiles in challenging therapeutic areas.