The FDA’s pediatric advisory committee voted nearly unanimously to continue post-market surveillance of 21 drugs and three vaccines, including high-profile products such as Novartis’ Entresto and Merck’s Gardasil 9 HPV vaccine. This ongoing monitoring reflects the agency’s commitment to drug safety in pediatric populations. In other regulatory news, the FDA approved a modified dosing regimen for Lilly’s Alzheimer’s drug Kisunla to reduce risks of brain swelling, addressing concerns impacting physician prescribing. Separate reports indicate stable novel drug approval volumes in the first half of 2025 and increasing frequencies of pre-submission interactions between device manufacturers and regulators, signaling shifts in regulatory dynamics.