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EMA and the Heads of Medicines Agencies (HMA), through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), have issued recommendations to address vulnerabilities in the supply chain of radiopharmaceuticals. These types of medicines contain radioactive forms of chemical elements called radioisotopes and are used to diagnose or treat medical conditions such as cancer. Their use is steadily increasing, …

Tackling vulnerabilities in the supply chain of radiopharmaceuticals in the EU Read More »

The Clinical Trials Information System (CTIS) has been designated as a primary registry by the World Health Organisation (WHO) within the International Clinical Trials Registry Platform (ICTRP). Becoming a primary registry means CTIS adheres to specific criteria for content, data quality and validity, accessibility, unique identification, technical capacity, and administration. This ensures comprehensive research information is accessible to healthcare decision-makers …

Clinical Trials Information System designated as WHO primary registry Read More »

For the first time in over ten years, the US Food and Drug Administration (FDA) has approved a new targeted treatment for chronic spontaneous urticaria. Sanofi and Regeneron Pharmaceuticals collaborated to develop Dupixent® (dupilumab). Under the FDA’s new authorisation, the therapy is indicated for individuals aged 12 years and over with the chronic inflammatory skin disease, who still experience …

FDA approves novel therapy for chronic skin condition Read More »

Researchers have suggested a potential approach to measure the effective work of powder adhesion between particle-surface contact, using the drop test method. Specifically, they assessed irregularly shaped ibuprofen powders and spherical aluminium-alloy powders. Citing current adhesion challenges during tablet manufacturing, the authors highlighted the need to “numerically predict if a new formulation may exhibit adhesion problems earlier [in …

Automated particle image analysis could optimise powder adhesion measurement Read More »

New Phase III data has demonstrated the potential benefit of the monoclonal antibody obinutuzumab to treat lupus nephritis. This therapy is already approved for B cell malignancies.

On April 23, 2025, the Food and Drug Administration approved penpulimab-kcqx (Akeso Biopharma Co., Ltd.) with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). FDA also approved penpulimab-kcqx as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after …

FDA approves penpulimab-kcqx for non-keratinizing nasopharyngeal carcinoma Read More »