News about "European Commission "

Lundbeck's Asedebart Receives EU Orphan Designation for Cushing's Syndrome

Lundbeck’s asedebart receives orphan designation in the European Union for Cushing’s syndrome, supporting its development as a potential targeted therapy for ACTH-driven endocrine disorders.

European Commission | 25/08/2026 | By News Bureau

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.

European Commission | 10/08/2026 | By News Bureau

EU Approves Datroway for First-Line Metastatic TNBC

The European Union (EU) has approved AstraZeneca and Daiichi Sankyo's Datroway for first-line metastatic Triple Negative Breast Cancer (TNBC), backed by positive phase 3 survival and PFS results.

European Commission | 01/08/2026 | By News Bureau |  111

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.

European Commission | 31/07/2026 | By News Bureau

CHMP Recommends EU Approval for NewAmsterdam Pharma's Obicetrapib Therapies to Treat High Cholesterol

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.

European Commission | 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.

European Commission | 27/07/2026 | By News Bureau

CHMP Recommends AstraZeneca's Trixeo for EU Approval in Asthma

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended EU approval of AstraZeneca's Trixeo for asthma maintenance, backed by positive phase 3 KALOS and LOGOS trial results.

European Commission | 25/07/2026 | By News Bureau |  132

CHMP Recommends EU Approval of Roche's Susvimo

The Committee for Medicinal Products for Human Use (CHMP) has recommended EU approval of Roche's Susvimo, the first continuous delivery treatment offering an alternative to regular eye injections for wet Age-related Macular Degeneration (AMD).

European Commission | 25/07/2026 | By News Bureau

EU Approves AstraZeneca's Etcamah Combination for ESR1-Mutated Advanced Breast Cancer

The European Commission has approved AstraZeneca’s Etcamah in combination with CDK4/6 inhibitors for ESR1-mutated ER-positive, HER2-negative advanced breast cancer, following Phase 3 data demonstrating a 56% reduction in the risk of disease progression or death.

European Commission | 24/07/2026 | By News Bureau

TolerogenixX Secures EU Orphan Drug Designation for MIC-Lx in Living-Donor Kidney Transplantation

European Commission grants orphan status to Tolerogenix’s personalized cell therapy following EMA recommendation, strengthening its regulatory pathway alongside recent PRIME designation.

European Commission | 14/07/2026 | By News Bureau