News about "European Union"

Slingshot Biosciences to Expand into UK and EU Markets

Slingshot Biosciences is expanding its operations into the United Kingdom and European Union to scale deployment of its precision-engineered synthetic cell mimic technology and accelerate cell and gene therapy as well as broader pharmaceutical development.

European Union | 05/02/2026 | By News Bureau |  100

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.

European Union | 04/02/2026 | By News Bureau |  115

EU recommends Rezurock for CHMP approval to treat chronic GVHD

The CHMP’s positive opinion, backed by clinical trial data and real-world evidence, paves the way for Rezurock’s potential approval in the EU as a new treatment option for adult and paediatric patients aged 12 years and above with late-line chronic graft-vs-host disease.

European Union | 02/02/2026 | By News Bureau

Abbott Secures CE Mark for TactiFlex Duo Ablation Catheter to Treat Atrial Fibrillation in Europe

Abbott has received CE Mark approval for its TactiFlex Duo Ablation Catheter, enabling dual-energy AFib treatment in Europe and marking successful first commercial procedures across the EU.

European Union | 21/01/2026 | By News Bureau |  197

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.

European Union | 20/01/2026 | By News Bureau |  168

Valneva and Serum Institute End Chikungunya Vaccine Licensing Deal

Valneva SE and the Serum Institute of India have mutually agreed to discontinue their licensing agreement for Valneva’s single-shot chikungunya vaccine, bringing the collaboration to a close by mutual consent.

European Union | 01/01/2026 | By News Bureau

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.

European Union | 24/12/2025 | By News Bureau |  116

EU Approves Insmed's BRINSUPRI, the First Treatment for Non-CF Bronchiectasis

The European Commission has approved BRINSUPRI as the first treatment for Non-Cystic Fibrosis Bronchiectasis, offering a new option for patients with this serious, progressive lung disease. The first-in-class DPP1 inhibitor was granted accelerated assessment by the EMA, reflecting its significant public health importance.

European Union | 19/11/2025 | By Dineshwori |  224

EMA Recommends EU Approval for Waskyra to Treat Wiskott-Aldrich Syndrome

The EMA has recommended EU marketing authorisation for Waskyra (etuvetidigene autotemcel), a gene therapy for patients aged six months and older with Wiskott-Aldrich Syndrome (WAS). The treatment uses a patient’s own modified stem cells to restore functional WAS protein.

European Union | 17/11/2025 | By Dineshwori |  231

EU Approves KEYTRUDA for PD-L1+ Resectable Head and Neck Cancer

KEYTRUDA monotherapy has been approved for use as a neoadjuvant treatment, followed by adjuvant therapy in combination with radiotherapy with or without cisplatin, and continued thereafter as maintenance monotherapy.

European Union | 30/10/2025 | By Dineshwori |  199