News about "CHMP"

EU Approves Sanofi's MenQuadfi for Invasive Meningococcal Disease

Sanofi's MenQuadfi has received European Union (EU) approval for infants from 6 weeks of age, expanding protection against invasive meningococcal disease.

CHMP | 04/08/2026 | 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.

CHMP | 01/08/2026 | By News Bureau |  115

EU Approves Pfizer-BioNTech XFG-Adapted COVID-19 Vaccine

The European Commission (EC) has approved Pfizer-BioNTech's XFG-adapted COVID-19 vaccine, with more than 5 billion vaccine doses distributed worldwide.

CHMP | 30/07/2026 | By News Bureau

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).

CHMP | 25/07/2026 | By News Bureau

Chiesi Global Rare Diseases Announces EC Approval of Lojuxta Capsules

Chiesi Global Rare Diseases has secured European Commission approval for Lojuxta (lomitapide) in children aged 5 years and older with Homozygous Familial Hypercholesterolaemia (HoFH), expanding treatment options for this ultra-rare genetic cholesterol disorder across the EU.

CHMP | 08/06/2026 | By News Bureau

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 |  243

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 |  178

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 |  172

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 |  234

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 |  207