Regulatory environments continue to evolve, impacting clinical trial ecosystems and product labeling. The European pharmaceutical industry coalition urged swift implementation of the new EU Life Science Strategy to rescue clinical trials from a precarious state. In the US, Democratic attorneys general filed suit challenging a new Affordable Care Act rule potentially restricting healthcare access. FDA advisory panels called for removal of black box warnings on menopausal hormone therapy, citing outdated risk data, while the FDA released updated guidance on use of external data in oncology drug combination approvals. Enforcement actions persist, highlighted by an FDA warning letter to Daewoo Pharmaceutical over contamination risks, underscoring ongoing regulatory vigilance in biopharma quality and compliance.