News about "Committee for Medicinal Products for Human Use "

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 |  201

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 |  125

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 |  131

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 |  194

European Commission Approves Sobi's Aspaveli for Rare Kidney Diseases C3G and IC-MPGN

The European Commission has approved Sobi’s Aspaveli for adolescents and adults with rare kidney diseases C3G and IC-MPGN, marking the first approved therapy for these conditions.

Committee For Medicinal Products For Human Use | 19/01/2026 | By News Bureau |  196

EU Approves Sanofi's Wayrilz as First BTK Inhibitor for Immune Thrombocytopenia

Sanofi has received EU approval for Wayrilz, the first Bruton’s Tyrosine Kinase (BTK) inhibitor indicated for immune thrombocytopenia, offering a novel multi-immune modulation approach. The approval is based on positive results from LUNA 3 study, which demonstrated rapid and durable platelet responses.

Committee For Medicinal Products For Human Use | 24/12/2025 | By News Bureau |  162

Lupin Secures Positive CHMP Opinion for Ranibizumab Biosimilar

Lupin has received a positive opinion from the CHMP for its ranibizumab biosimilar, supported by comprehensive analytical similarity data and a global Phase III clinical trial involving 600 patients with neovascular Age-related Macular Degeneration (AMD).

Committee For Medicinal Products For Human Use | 18/12/2025 | By News Bureau |  155

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.

Committee For Medicinal Products For Human Use | 15/11/2025 | By Dineshwori |  344

Novo Nordisk Expects EC Approval of Alhemo Label Update for Haemophilia in 2 Months

Novo Nordisk has received a positive opinion from EMA’s Committee for Medicinal Products for Human Use (CHMP) for expanded Alhemo use in haemophilia without inhibitors.

Committee For Medicinal Products For Human Use | 26/07/2025 | By Dineshwori |  451