The European Medicines Agency has granted orphan drug designation for zocilurtatug pelitecan, an investigational DLL3-targeted antibody-drug conjugate, based on ...

Belgium Fast Access Medicines has moved from policy to practice. Authorities have granted temporary reimbursement to Atrasentan, the first therapy approved under the new Early and Equitable Fast Access procedure, offering quicker hope to patients with IgA nephropathy while anchoring the country’s...

The Retracted Trial Publication of the ADVOCATE study has eliminated the central evidence that supported approval of Tavneos (avacopan) for severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (AAV). At the request of two lead academic authors, the

The MHRA’s validation of Nuvation Bio’s marketing authorisation application marks an important regulatory validation taletrectinib for adults with advanced ROS1-positive non-small cell lung cancer. This milestone, achieved via the International Recognition Procedure in parallel with EMA review, f...

Portuguese Biotech Innovation has matured into a compelling global force, with Solfarcos marking a decade of translating University of Minho research into commercial technologies that span cosmetics and pharmaceuticals. The Braga-based spin-off has built a unified platform of peptides and protein...

Portugal’s medicines regulator INFARMED has been shaken by a major case of cannabis regulatory exploitation in which criminal networks weaponised medicinal cannabis licences to traffic drugs on an industrial scale. Insufficient inspectors, rapid sector growth and the recruitment of former agency ...