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Khabre desk
Recent reporting, analysis and explainers from the EU regulation desk.
health
The EMA’s veterinary medicines committee issued positive opinions on five marketing-authorisation applications, including Scovella under the EU limited-market framework. It also adopted a new report on antimicrobial use and resistance in humans and animals.
health
EMA’s human medicines committee recommended six new medicines and five extensions of existing medicines’ indications at its 12–15 October 2026 meeting. The recommendations are not final EU marketing authorisations.
health
The EMA’s human medicines committee recommended EU marketing authorisation for Rasonque, an oral treatment for adults with previously treated metastatic pancreatic adenocarcinoma. In a phase 3 study reported by EMA, median overall survival was 12.4 months with Rasonque and 6.7 months with chemotherapy.
health
The European Medicines Agency plans to begin work on a modernised Clinical Trials Information System platform in early 2027. The upgrade is intended to support changes proposed in the EU Biotech Act, which remains under discussion.
health
The European Medicines Agency says new manufacturing sites for Visudyne have been approved, reducing reliance on a single US-based active-substance site. Full supply across the European Union is expected to be restored in 2027.