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Results For "European-Commission"

142 News Found

EMA and HMA to strengthen Anti-D Immunoglobulin supply chain
News | July 08, 2025

EMA and HMA to strengthen Anti-D Immunoglobulin supply chain

These medicines are essential in preventing RhD immunisation during pregnancy


Biocon Biologics receives MHRA UK approval for Vevzuo and Evfraxy, Denosumab Biosimilars
News | July 07, 2025

Biocon Biologics receives MHRA UK approval for Vevzuo and Evfraxy, Denosumab Biosimilars

Vevzuo is authorized for the prevention of skeletal related events in adults with advanced malignancies involving bone


Imfinzi approved in the EU as first and only perioperative immunotherapy for muscle-invasive bladder cancer
Clinical Trials | July 06, 2025

Imfinzi approved in the EU as first and only perioperative immunotherapy for muscle-invasive bladder cancer

Approval based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death for the Imfinzi regimen vs. neoadjuvant chemotherapy alone


AstraZeneca’s fixed-duration Calquence-based regimens approved in EU for patients with chronic lymphocytic leukaemia
News | June 07, 2025

AstraZeneca’s fixed-duration Calquence-based regimens approved in EU for patients with chronic lymphocytic leukaemia

AMPLIFY Phase III trial results demonstrated statistically significant and clinically meaningful improvement in progression-free survival for Calquence combinations


Biocon Biologics receives MHRA, UK approval for biosimilar YESINTEK
News | May 26, 2025

Biocon Biologics receives MHRA, UK approval for biosimilar YESINTEK

YESINTEK is indicated for the treatment of adults and children from the age of 6 years and olde


Briefs: Zydus and CuraTeQ Biologics
Drug Approval | May 14, 2025

Briefs: Zydus and CuraTeQ Biologics

CuraTeQ Biologics receives approval for biosimilar Zefylti from UK’s MHRA


CHMP recommends EU label update for Roche’s Phesgo to allow administration outside of clinical settings
Clinical Trials | May 01, 2025

CHMP recommends EU label update for Roche’s Phesgo to allow administration outside of clinical settings

Phesgo label expansion delivers on patients’ preference for at-home administration and is an important step in freeing up cancer care capacity in clinical settings


Biocon Biologics receives positive CHMP opinions for biosimilar Denosumab in Europe
Drug Approval | April 28, 2025

Biocon Biologics receives positive CHMP opinions for biosimilar Denosumab in Europe

The positive opinions are based on applications submitted by Biosimilar Collaborations Ireland Limited


CuraTeQ Biologics receives positive opinion for biosimilar Dazublys from EMA
Drug Approval | April 28, 2025

CuraTeQ Biologics receives positive opinion for biosimilar Dazublys from EMA

Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein


AstraZeneca’s Imfinzi-based perioperative regimen approved in EU for resectable non-small cell lung cancer
Drug Approval | April 04, 2025

AstraZeneca’s Imfinzi-based perioperative regimen approved in EU for resectable non-small cell lung cancer

Approval based on AEGEAN Phase III trial results which showed a 32% reduction in the risk of recurrence, progression or death vs. neoadjuvant chemotherapy alone