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News about "marketing authorisation"
EMA Recommends EU Approval for Waskyra to Treat Wiskott-Aldrich Syndrome
The EMA has recommended EU marketing authorisation for Waskyra (etuvetidigene autotemcel), a gene therapy for patients aged six months and older with Wiskott-Aldrich Syndrome (WAS). The treatment uses a patient’s own modified stem cells to restore functional WAS protein.
Marketing Authorisation | 17/11/2025 | By Dineshwori | 103
Relonchem Gets MHRA Nod for Exemestane 25 mg Tablets
Exemestane by Relonchem, a subsidiary of Markans Pharma, is an aromatase inhibitor used in the treatment of hormone-dependent breast cancer in postmenopausal women. The approval marks another milestone in Marksans Pharma’s strategy to expand its oncology portfolio and strengthen its presence in the UK and European markets.
Marketing Authorisation | 05/11/2025 | By Dineshwori | 138
Biocon Biologics Receives European Commission Nod for Denosumab Biosimilars to Improve Bone Health
Biocon Biologics has received European Commission approval for its Denosumab biosimilars, Vevzuo and Evfraxy, thereby expanding access to advanced treatments for bone-related conditions across the EU.
Marketing Authorisation | 03/07/2025 | By Mrinmoy Dey | 173
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