News about "CHMP"

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.

CHMP | 05/03/2026 | By News Bureau |  171

EMA Panel Backs Norgine?s XOLREMDI for WHIM Syndrome Under Exceptional Circumstances

The EMA’s CHMP recommends marketing authorisation for XOLREMDI (mavorixafor) to treat WHIM syndrome patients aged 12 and above, marking a major step toward the first licensed therapy for the rare disorder.

CHMP | 03/03/2026 | By News Bureau |  101

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.

CHMP | 24/02/2026 | 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.

CHMP | 16/02/2026 | By News Bureau |  126

CHMP Recommends Imfinzi for Early Gastric Cancers

The EU’s CHMP has recommended approval of AstraZeneca’s Imfinzi perioperative regimen for early gastric and gastroesophageal cancers following positive phase-III MATTERHORN data, showing a 29 percent reduction in progression or recurrence risk and a 22 percent reduction in mortality versus chemotherapy alone.

CHMP | 04/02/2026 | By News Bureau |  115

J&J Wins CHMP Nod for AKEEGA in BRCA-Mutated mHSPC

Backed by positive AMPLITUDE trial results, the CHMP opinion supports AKEEGA in BRCA-mutated mHSPC, showing delayed disease progression and early signs of improved Overall Survival (OS) versus standard of care.

CHMP | 02/02/2026 | By News Bureau

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.

CHMP | 28/01/2026 | By News Bureau |  111

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.

CHMP | 20/01/2026 | By News Bureau |  168

Japan Approves Exdensur for Severe Asthma and Nasal Polyps

Japan has approved Exdensur (depemokimab) for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP), marking the first ultra-long-acting biologic in the country, with approval supported by phase-III SWIFT and ANCHOR trial data demonstrating sustained efficacy with twice-yearly dosing.

CHMP | 07/01/2026 | By News Bureau |  261

China Approves Nucala from GSK for Adult COPD Treatment

China has approved Nucala (mepolizumab) for adult COPD, supported by phase-III MATINEE and METREX trials showing reduced exacerbations in patients with blood eosinophil counts from 150 cells/µL.

CHMP | 06/01/2026 | By News Bureau |  248