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Results For "CHMP"

88 News Found

EMA accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis
News | December 05, 2022

EMA accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis

Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints


USFDA grants priority review of BLA for dengue vaccine TAK-003
Drug Approval | November 23, 2022

USFDA grants priority review of BLA for dengue vaccine TAK-003

If approved, TAK-003 has the potential to become an important dengue prevention option for healthcare providers


Stelis receives recommendation from EMA granting market authorization for Kauliv
Drug Approval | November 14, 2022

Stelis receives recommendation from EMA granting market authorization for Kauliv

Kauliv provides reusable and disposable pen2 device options to cater to the global market demand.


Sanofi, GSK’s next-generation COVID-19 booster vaccine approved by the European Commission
Drug Approval | November 11, 2022

Sanofi, GSK’s next-generation COVID-19 booster vaccine approved by the European Commission

First and only next-generation protein-based adjuvanted COVID-19 booster approved in Europe


Tezspire approved in the EU for the treatment of severe asthma
Drug Approval | September 21, 2022

Tezspire approved in the EU for the treatment of severe asthma

First and only biologic approved in the EU in patients with severe asthma with no phenotype or biomarker limitations


Novartis receives EC approval for Tabrecta for the treatment of non-small cell lung cancer
Drug Approval | June 24, 2022

Novartis receives EC approval for Tabrecta for the treatment of non-small cell lung cancer

Tabrecta is the number one prescribed targeted therapy for advanced NSCLC with alterations leading to METex14 skipping globally


Vaxzevria approved in the EU as third dose booster against Covid-19
Drug Approval | May 23, 2022

Vaxzevria approved in the EU as third dose booster against Covid-19

Approval follows CHMP recommendation for use in patients previously vaccinated with Vaxzevria or an EU-approved mRNA Covid-19 vaccine


NovoSeven recommended for approval for the treatment of severe postpartum haemorrhage by the European Medicines Agency
Biotech | April 23, 2022

NovoSeven recommended for approval for the treatment of severe postpartum haemorrhage by the European Medicines Agency

Heavy bleeding after giving birth is globally a leading cause of death in new mothers


Evusheld recommended for market authorisation in EU
Biotech | March 25, 2022

Evusheld recommended for market authorisation in EU

Recommendation based on Phase III PROVENT trial showing a significant reduction in the risk of developing symptomatic COVID-19, with protection lasting at least six months


Health Canada authorizes Moderna's COVID-19 vaccine in children (6-11 Years)
News | March 18, 2022

Health Canada authorizes Moderna's COVID-19 vaccine in children (6-11 Years)

The announcement follows recent authorization of the Company's mRNA COVID-19 vaccine in Australia and the European Union for children aged 6-11 years