News about "Committee for Medicinal Products for Human Use "

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.

Committee For Medicinal Products For Human Use | 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.

Committee For Medicinal Products For Human Use | 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.

Committee For Medicinal Products For Human Use | 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.

Committee For Medicinal Products For Human Use | 27/07/2026 | 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.

Committee For Medicinal Products For Human Use | 24/07/2026 | By News Bureau

EMA Panel Recommends Revoking EU Authorisation for Tavneos Over Data Integrity Concerns

CHMP concludes pivotal clinical trial data cannot reliably demonstrate the drug’s efficacy, advises discontinuation for new patients and enhances liver monitoring for existing users.<br />

Committee For Medicinal Products For Human Use | 29/06/2026 | By News Bureau |  111

Ipsen receives positive EMA panel opinion for Ojemda to treat paediatric low-grade glioma

European Medicines Agency’s CHMP recommends conditional approval of Ojemda (tovorafenib) for children with BRAF-altered paediatric low-grade glioma, offering a potential targeted therapy option for relapsed or refractory cases.

Committee For Medicinal Products For Human Use | 05/03/2026 | By News Bureau |  242

Lupin Secures European Commission Approval for Ranluspec, Biosimilar Ranibizumab

European Commission clears Lupin’s biosimilar ranibizumab, Ranluspec, for multiple retinal disorders; Sandoz to commercialise across the EU, expanding access to affordable biologics.

Committee For Medicinal Products For Human Use | 24/02/2026 | By News Bureau |  171

European Commission Expands Bracco's Vueway Approval to Infants and Neonates

Bracco Imaging secures EU approval to extend Vueway’s use to infants and neonates, enhancing safe and effective MRI diagnostics for young patients.

Committee For Medicinal Products For Human Use | 28/01/2026 | By News Bureau |  169

EU Validates ENHERTU Plus Pertuzumab for First-Line HER2-Positive Metastatic Breast Cancer

The European Union (EU) has validated the first-line use of ENHERTU in combination with pertuzumab for patients with HER2-positive metastatic breast cancer, following results from the DESTINY-Breast09 phase-III trial, which demonstrated a significant improvement in Progression-Free Survival (PFS) compared to current standard treatments.

Committee For Medicinal Products For Human Use | 20/01/2026 | By News Bureau |  234