Regulatory round-up: 23 September 2025

Europe’s medicines committee wrapped up its September meeting with a flurry of activity, backing 14 new medicines and recommending six additional indication extensions. The list included therapies for RSV, generalized myasthenia gravis, type 2 diabetes, and menopause symptoms, alongside nine biosimilars and a generic awaiting final Commission approval.

In the USA, the regulator moved on two fronts. It granted accelerated approval to Forzinity (elamipretide), the first treatment for the ultra-rare Barth syndrome, while also issuing draft guidance aimed at hastening development of non-opioid analgesics for chronic pain. Both decisions underline its push to expand therapeutic options while addressing safety concerns.

North of the border, Health Canada tightened controls on melatonin, shifting it onto the Prescription Drug List for human use and opening a consultation on how to regulate pediatric formulations. In Australia, authorities updated clinicians on ongoing methylphenidate shortages, highlighting continued reliance on section 19A import approvals to manage supply.