Here is our regular summary of content of relevance to neurology from the Human Medicines Highlights – August 2026
Key EMA News Updates:
- EMA fast-tracks review of medicine for metastatic pancreatic cancer
The EMA has started a phased review of daraxonrasib for metastatic pancreatic cancer, allowing the available data to be assessed in stages as they emerge, with the aim of accelerating the regulatory evaluation while maintaining rigorous standards. Click here for more details: EMA fast tracks review of a medicine for metastatic pancreatic cancer | European Medicines Agency (EMA)
- New leadership team appointments at EMA
Following Ivo Claessen’s retirement, Melanie Carr, the EMA’s Head of the Stakeholders and Communication Division, has been assigned Deputy Executive Director duties. Franck Fourès has been appointed Head of the Veterinary Medicines Division. Click here for more details: New leadership team appointments | European Medicines Agency (EMA)
- EMA and EISMEA strengthen cooperation on health innovation
The EMA and the European Innovation Council and SMEs Executive Agency (EISMEA) have strengthened their collaboration to support and accelerate health innovation across the EU. Click here for more details: EMA and EISMEA boost cooperation to accelerate health innovations | European Medicines Agency (EMA)
- Emer Cooke’s speech to the European Parliament’s Public Health Committee
The EMA has published Executive Director Emer Cooke’s annual exchange of views with the European Parliament’s Committee on Public Health (SANT), addressing the agency’s current work and priorities. Click here for more details: Executive Director Emer Cooke’s speech at the European Parliament’s Committee on Public Health | European Medicines Agency (EMA)
- Inside EMA podcast – innovation in animal testing
The latest episode explores how the EMA is supporting innovative alternatives to animal studies, focusing on new approaches that could improve science while reducing reliance on animal testing. Click here for more details: Podcast: Inside EMA | European Medicines Agency (EMA)
Medicines:
- Nezglyal (leriglitazone)
New medicine recommended for approval – On 23 July 2026, the CHMP adopted a positive opinion recommending marketing authorisation under exceptional circumstances for Nezglyal for the treatment of cerebral adrenoleukodystrophy (cALD). Leriglitazone is a selective PPARγ agonist that crosses the blood–brain barrier and has antioxidant and neuroprotective effects, potentially reducing neuroinflammation and promoting myelination and mitochondrial function. Click here for more details: Nezglyal | European Medicines Agency (EMA)
- Vyvgart (efgartigimod alfa)
Direct Healthcare Professional Communication (DHPC) – A potential quality defect affecting specific batches of Vyvgart 1,000 mg solution for injection has been reported, with possible visible contamination. Healthcare professionals, patients and caregivers should visually inspect vials before use and not use the product if it is discoloured or contains visible particles. Vyvgart is indicated for the treatment of AChR antibody-positive generalised myasthenia gravis and progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP). Click here for more details: Vyvgart – direct healthcare professional communication (DHPC) | European Medicines Agency (EMA)
