EMA has recommended extending the therapeutic indication of Zynyz (retifanlimab) to include treatment of adults with squamous cell carcinoma of the anal canal (SCAC) that cannot be removed by surgery and is metastatic or locally...
Immunoglobulins were first used as replacement therapy in patients with humoral immunodeficiency and are now used for both primary immunodeficiencies (PID) and several secondary immunodeficiencies. They are also used for immunomodulatory indications in patients with...
“Pour répondre aux orientations inscrites dans le Contrat d’objectifs et de performance qui nous lie avec l’État, notre établissement a défini son projet stratégique « EFS 2028 : plus loin ensemble ». ” En savoir...
Symbole de cet engagement, l’établissement vient de créer une direction nationale dédiée à la production de biomédicaments. Objectif : renforcer l’activité des plateformes de production de l’EFS et participer ainsi aux objectifs fixés par le...
EMA has recommended granting a marketing authorisation in the European Union (EU) for Aqneursa (levacetylleucine) for the treatment of neurological manifestations of Niemann-Pick type C (NPC) disease in adults and children aged six years and older and...
The main aim of the guideline is to address general guidance on the development of medicinal products for the diagnosis and immunotherapy of allergies, where only moderate to low-sized study populations are available in product...
EDQM On Air has just released a new episode on biological medicinal products discussing the history and evolution of these products, how they are at the cutting-edge of pharmaceutical science and have contributed to major...
Biological medicinal products – or biologicals – are a class of pharmaceutical products derived or refined from biological sources including micro-organisms, animal tissue and even human cells. These extremely powerful and versatile medicines are at...
In line with the haematology work plan for 2025, this online workshop was organised to have a multi-stakeholder’s perspective on the use of immunoglobulins as the scientific guideline on the clinical investigation of human normal immunoglobulin for...
The US Food and Drug Administration (FDA) has issued draft guidance to assist manufacturers in complying with its good manufacturing practice (GMP) regulations under 21 CFR 211.110 governing batch uniformity for drug and biological products....
