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Khabre desk
Recent reporting, analysis and explainers from the medicines desk.
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 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
EMA advises marketing authorisation holders to submit specified Type IA variations by 20 November and Type IB filings by 30 November 2026. The dates are tentative and may shift with submission volumes and complexity.
health
The European Medicines Agency plans to publish a roadmap by the end of 2026 to improve how women’s health is considered in medicines development and regulation. Ten proposed priorities include better clinical-trial representation, stronger evidence and clearer communication of benefits and risks.
health
NHS England will make trastuzumab deruxtecan, sold as Enhertu, available to around 1,000 women with HER2-low advanced or metastatic breast cancer after their disease progresses following treatment.
health
EMA’s Committee for Medicinal Products for Human Use issued positive opinions for 12 medicines at its 14–17 September 2026 meeting, including a rabies vaccine, two biosimilars and two generics. The recommendations remain subject to European Commission decisions.