The EU authorisation introduces a pharmacological treatment for eligible boys with cerebral adrenoleukodystrophy under exceptional circumstances.

The European Commission has approved Ubeslo and Evlarco for treatment of primary hypercholesterolaemia or mixed dyslipidaemia, marking the first regulatory approval worldwide for obicetrapib.

The European Commission has authorised Icotyde for adults and adolescents with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.

The European Commission has approved Enhertu plus pertuzumab as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer.

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 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 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 decision makes Itvisma the first and only gene replacement therapy approved in the EU for older children, teenagers and adults living with 5q spinal muscular atrophy. The European Commission has approved Novartis' Itvisma (onasemnogene abeparvovec) for the treatment of older children, teenagers and adults with 5q spinal muscular atrophy (SMA) who have a bi-allelic mutation in the survival motor neuron 1 (SMN1) gene. The approval significantly expands access to gene replac

First-in-class B-cell therapy now available as an add-on treatment for adults with gMG, supported by Phase III MINT trial outcomes.