News about "CHMP"

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

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

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

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 |  144

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 |  224

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 |  191

CHMP Recommends Sanofi's Tezeild for EU Approval in Stage 2 Type 1 Diabetes

The CHMP has backed EU approval for Sanofi’s Tezeild, supported by TN-10 study results showing the therapy can delay progression to stage 3 type 1 diabetes in patients with stage 2 disease. If authorised, Tezeild would become the first disease-modifying treatment for T1D in the EU.

CHMP | 15/11/2025 | By Dineshwori |  270

Dr. Reddy's Receives Positive CHMP Opinion from European Medicines Agency for Denosumab

Dr. Reddy’s Laboratories has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for AVT03, a proposed biosimilar to Prolia and Xgeva, moving it closer to potential marketing authorisation in the European Economic Area (EEA).

CHMP | 24/09/2025 | By Dineshwori |  151