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Results For "European-Medicines-Agency"

193 News Found

Novo Nordisk submits application to EMA for higher dose of Wegovy for obesity treatment
Clinical Trials | July 09, 2025

Novo Nordisk submits application to EMA for higher dose of Wegovy for obesity treatment

The submission is based on data from the STEP UP and STEP UP T2D clinical trials


AB Science receives FDA and EMA authorization for phase 3 Trial of prostate cancer treatment
Clinical Trials | July 08, 2025

AB Science receives FDA and EMA authorization for phase 3 Trial of prostate cancer treatment

Masitinib is targeted at patients who are no longer responding to hormone-sensitive prostate cancer treatments


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
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


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