Regulatory round-up: 29 September 2025

Over the past week, regulatory updates spanned approvals, safety statements and policy shifts. The Food and Drug Administration (FDA) authorized imlunestrant for ESR1-mutated advanced breast cancer, while Australia’s Therapeutic Goods Administration (TGA0 reversed an earlier rejection and approved lecanemab for early Alzheimer’s disease in specific populations. These highlight regulators’ evolving stance on targeted oncology and neurodegenerative therapies.

Meanwhile, the European Medicines Agency (EMA), the UK Medicines and Healthcare products Agency (MHRA) and Swissmedic all moved to reassure the public that paracetamol remains a safe option during pregnancy when clinically indicated. The UK regulator also issued fresh enforcement notices on weight-loss drug advertising and illegal Botox sales, signaling a more assertive approach to consumer protection.

On the policy front, the EMA introduced new variations guidelines and, alongside the European Commission and HMA, set ambitious targets to boost clinical trial activity in Europe. These include faster start-up times and a marked increase in multinational studies, reflecting pressure to reinvigorate the EU’s research competitiveness.