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News about "marketing authorisation"
European Commission Approves Bavarian Nordic's MVA-BN Vaccine for Children Aged 2 and Older
Bavarian Nordic’s MVA-BN vaccine, Imvanex, is now authorised in the EU for children aged 2 years and older, expanding protection against mpox and smallpox among vulnerable populations.
Marketing Authorisation | 10/08/2026 | By News Bureau
European Commission Approves Pfizer-BioNTech's XFG-Adapted COVID-19 Vaccine for 2026-27 Season
The European Commission has approved Pfizer and BioNTech's monovalent XFG-adapted COVID-19 vaccine for the 2026–27 vaccination season that authorised for people aged six months and above, is designed to enhance protection against currently circulating SARS-CoV-2 variants and will be supplied across the European Union and selected European countries.
Marketing Authorisation | 31/07/2026 | By News Bureau
NewAmsterdam Pharma and Menarini have received a positive CHMP opinion for Ubeslo and Evlarco, bringing the oral obicetrapib-based therapies one step closer to EU approval for patients with hypercholesterolaemia and mixed dyslipidaemia.
Marketing Authorisation | 27/07/2026 | By News Bureau
EMA Backs Marketing Authorisation for Janssen's Icotyde in Plaque Psoriasis
CHMP backs marketing authorisation for icotrokinra to treat moderate-to-severe plaque psoriasis in adults and eligible adolescents, potentially making it the first oral IL-23-targeting therapy approved in the EU.
Marketing Authorisation | 27/07/2026 | By News Bureau
UK MHRA Approves Wegovy for Treatment of MASH in Adults with Liver Fibrosis
The UK's Medicines and Healthcare products Regulatory Agency has conditionally approved Novo Nordisk's Wegovy (semaglutide) for treating metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advanced liver fibrosis, subject to ongoing confirmatory clinical data.
Marketing Authorisation | 06/07/2026 | By News Bureau
EMA Expands PRIME Programme with New Tools to Accelerate Drug Development
EMA introduces three new features to its PRIME scheme, enhancing regulatory support, speeding scientific advice, and improving readiness for marketing authorisation submissions.
Marketing Authorisation | 21/03/2026 | By News Bureau
STADA and Bio-Thera Secure EU Marketing Approval for Golimumab Biosimilar Gotenfia
European Commission authorises Gotenfia, referencing Simponi, for multiple autoimmune diseases across EU and EEA markets.
Marketing Authorisation | 16/02/2026 | By News Bureau | 234
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 | 298
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 | 304
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 | 265
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