Regulatory round-up: 3 November 2025

In the last week on the regulatory front, the European Medicines Agency (EMA) safety committee, the Pharmacovigilance Risk Assessment Committee (PRAC), completed its 27-30 October session and decided to issue a targeted professional communication on injectable forms of tranexamic acid, signalling increased risk-management attention across the EU.

Meanwhile the EMA’s human medicines committee, the Committee for Medicinal Products for Human Use (CHMP), delivered a positive opinion on the novel treatment Brinsupri for non-cystic fibrosis bronchiectasis, which would mark the first such approved therapy if adopted.

In the USA, the Food and Drug Administration (FDA) cleared the antibody-drug conjugate Blenrep (belantamab mafodotin-blmf) in combination therapy for adults with relapsed or refractory multiple myeloma, broadening community-accessible options beyond academic centers.