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Results For "European-Medicines-Agency"

181 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


Philogen withdraws marketing authorization application for Nidlegy in EU
News | June 26, 2025

Philogen withdraws marketing authorization application for Nidlegy in EU

The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls


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


Biocon Biologics announces positive results from Phase 3 study of Yesintek biosimilar to Ustekinumab for chronic plaque psoriasis
Diagnostic Center | March 08, 2025

Biocon Biologics announces positive results from Phase 3 study of Yesintek biosimilar to Ustekinumab for chronic plaque psoriasis

The study demonstrated equivalent efficacy, safety, immunogenicity, and pharmacokinetics between YESINTEK and the reference product Stelara


European Commission approves Biocon Biologics' Ustekinumab Biosimilar
News | February 21, 2025

European Commission approves Biocon Biologics' Ustekinumab Biosimilar

YESINTEK, is intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn's disease


CuraTeQ Biologics receives positive opinion for biosimilar Dyrupeg from EMA
News | February 03, 2025

CuraTeQ Biologics receives positive opinion for biosimilar Dyrupeg from EMA

Dyrupeg will be available as 6 mg solution for injection in prefilled syringe and is intended for the reduction in the duration of neutropenia


Wockhardt’s Zaynich achieves highest-ever efficacy meeting superiority in a global, pivotal, registration- enabling Phase III study
Diagnostic Center | February 03, 2025

Wockhardt’s Zaynich achieves highest-ever efficacy meeting superiority in a global, pivotal, registration- enabling Phase III study

Such combined efficacy (achieving clinical cure and microbiologic cure) of Zaynich is highest ever among all the FDA-approved novel antibiotics developed in the last more than 10 years


BMS receives positive CHMP opinion for Opdivo plus Yervoy as a first-line treatment option for advanced hepatocellular carcinoma
News | February 01, 2025

BMS receives positive CHMP opinion for Opdivo plus Yervoy as a first-line treatment option for advanced hepatocellular carcinoma

Recommendation based on results of Phase 3 CheckMate -9DW clinical trial demonstrating statistically significant and clinically meaningful improvement in overall survival with Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib in this patient population