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Results For "European-Economic-Area"

9 News Found

Biocon Biologics receives European Commission approval for biosimilar of Aflibercept ‘Yesafili’
Drug Approval | September 21, 2023

Biocon Biologics receives European Commission approval for biosimilar of Aflibercept ‘Yesafili’

The centralized marketing authorization granted by the EC is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway


Myovant Sciences and Accord Healthcare partner to commercialise Orgovyx in Europe
Biotech | May 10, 2022

Myovant Sciences and Accord Healthcare partner to commercialise Orgovyx in Europe

Myovant to receive an upfront payment of US $50 million, is eligible to receive commercial launch, sales-based and other milestones totaling up to US $90.5 million


VBI’s 3-antigen Hepatitis B vaccine gets CHMP nod
Biotech | February 27, 2022

VBI’s 3-antigen Hepatitis B vaccine gets CHMP nod

If approved, PreHevbri will be the only approved 3-antigen hepatitis B vaccine for adults in the E.U.


EC approves Tepmetko to treat non-small cell lung cancer
Drug Approval | February 19, 2022

EC approves Tepmetko to treat non-small cell lung cancer

Tepmetko is the first and only oral MET inhibitor to be approved in the European Economic Area for treating adult patients with advanced NSCLC harboring alterations leading to METex14 skipping, who require systemic therapy following prior treatment


Indica Labs receive CE Mark for its HALO AP
Equipment | January 10, 2022

Indica Labs receive CE Mark for its HALO AP

The HALO AP platform was developed by Indica Labs to address the specific needs of anatomic pathology labs by supporting a wide range of tissue-based workflows, including primary diagnosis, secondary consults, tumour boards, clinical trials, synoptic reporting, quantitative analytics, and AI


Algorithmic Biologics receives CE mark for Tapestry platform
Startup | December 10, 2021

Algorithmic Biologics receives CE mark for Tapestry platform

The platform’s technology works as a compression algorithm for molecular testing


Lincoln Pharma gets Australian TGA approval
News | October 08, 2021

Lincoln Pharma gets Australian TGA approval

The company plans to expand its portfolio in regulated markets aggressively


Biocon and Viatris receive EC approval for Biosimilar Bevacizumab
Biotech | April 28, 2021

Biocon and Viatris receive EC approval for Biosimilar Bevacizumab

The drug is approved for the treatment in metastatic colorectal carcinoma, metastatic breast cancer and ovarian, cervical and renal cancer


Biocon Biologics and Viatris receive European Commission approval for Kixelle, Biosimilar Insulin Aspart
Biotech | February 13, 2021

Biocon Biologics and Viatris receive European Commission approval for Kixelle, Biosimilar Insulin Aspart

The centralized marketing authorization granted by the EC is valid in all EU Member