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Results For "Committee-for-Medicinal-Products-for-Human-Use"

98 News Found

Trixeo Aerosphere receives positive EU CHMP opinion as first inhaled medicine with near-zero GWP
Sustainability | July 31, 2025

Trixeo Aerosphere receives positive EU CHMP opinion as first inhaled medicine with near-zero GWP

Trixeo is the first pMDI medicine in AstraZeneca’s portfolio to use the near-zero GWP propellant


Roche updates on Elevidys gene therapy for Duchenne muscular dystrophy in EU
News | July 31, 2025

Roche updates on Elevidys gene therapy for Duchenne muscular dystrophy in EU

Elevidys is currently the only approved gene therapy that targets the root cause of Duchenne


EMA’s CHMP recommends authorization of Moderna's Covid-19 vaccine Spikevax for SARS-CoV-2 Variant LP.8.1
News | July 27, 2025

EMA’s CHMP recommends authorization of Moderna's Covid-19 vaccine Spikevax for SARS-CoV-2 Variant LP.8.1

Moderna's updated COVID-19 mRNA vaccine will be available for the 2025-2026 vaccination season, pending a European Commission authorization decision


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


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


Enhertu approved in EU in post-ET breast cancer
Drug Approval | April 04, 2025

Enhertu approved in EU in post-ET breast cancer

Approval brings AstraZeneca and Daiichi Sankyo’s Enhertu earlier in the treatment of HR-positive, HER2-low breast cancer and broadens the eligible patient population to those with HER2-ultralow disease