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News about "European Union"
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.
European Union | 01/08/2026 | By News Bureau | 115
PD-L1 IHC 22C3 pharmDx gains CE-marked indication to identify eligible patients with epithelial ovarian, fallopian tube and primary peritoneal carcinoma for pembrolizumab treatment.
European Union | 27/07/2026 | By News Bureau
EMA Fast-Tracks Review of New Metastatic Pancreatic Cancer Drug
The European Medicines Agency (EMA) has initiated a phased review of a new medicine for metastatic pancreatic cancer, accelerating its assessment to address a significant unmet medical need.
European Union | 09/07/2026 | By News Bureau
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 | 174
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 | 207
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 | 141
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 | 270
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 | 234
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 | 140
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 | 236
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