The Council has formally adopted its position on the EU pharmaceutical package, moving the bloc's largest overhaul of medicines legislation in decades toward its final legislative stages.

EU pharmaceutical legislation has moved closer to completion after member states backed the Council's first-reading positions on the regulation and directive forming the bloc's revised medicines framework.

The European Medicines Agency has opened consultation on a draft guideline addressing the design and interpretation of studies assessing drug absorption interactions within the gastrointestinal tract.

The authorisation gives patients aged five years and older the first treatment specifically approved for Rett syndrome across the European Union, with Acadia preparing for an initial German launch in the fourth quarter of 2026.

The approval establishes Trodelvy-based treatment across PD-L1 status in first-line metastatic TNBC in Europe, following the earlier authorisation of Trodelvy monotherapy for patients not eligible for PD-1/PD-L1 inhibitors.

The designation provides regulatory development incentives for Vanda’s IL-36 receptor inhibitor in the EU and follows orphan status for the investigational therapy in the US and Japan.

The new tool is intended to help health technology developers determine whether a medicinal product falls within the EU’s Joint Clinical Assessment requirements before entering the formal HTA process.

The EU Health Technology Assessment Regulation now requires eligible oncology medicines and advanced therapies to undergo a single European clinical assessment, increasing the importance of early evidence planning alongside EMA regulatory development.

Recent legal and regulatory developments could influence how innovative medicines are protected in Europe by changing the interaction between regulatory exclusivity, patent rights and generic market entry.

The updated vaccine is authorised for individuals aged six months and older and aligns the EU COVID-19 vaccination programme with the currently circulating XFG variant.

The two regulatory decisions could expand first-line treatment options for patients with ESR1-mutant ER-positive disease and HER2-positive metastatic breast cancer, although Enhertu still requires European Commission approval.

If authorised, Icotyde would become the first oral treatment targeting the interleukin-23 receptor available to eligible adults and adolescents in the EU.

Positive opinion based on Phase 3 BRAVE-AA-PEDS trial supports first-in-class JAK inhibitor therapy for young patients with profound hair loss.