Regulatory round-up: 29 October 2025

The European Medicines Agency (EMA) and its Committee for Medicinal Products for Human Use (CHMP) set the pace in Europe, with the CHMP issuing strong recommendations: one for the first-ever treatment for non-cystic fibrosis bronchiectasis and another confirming a suspension for a sickle-cell-disease medicine.

In the US, the Food and Drug Administration (FDA) delivered key oncology approvals, including a new indication for a menin inhibitor in NPM1-mutated acute myeloid leukemia.

Meanwhile, in Asia, the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan posted critical safety-label revisions, and the National Medical Products Administration (NMPA) of China published new approval-certificate batches: underlining ongoing regulatory housekeeping across major markets.