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Results For "CHMP"

103 News Found

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


Nirsevimab EMA regulatory submission accepted under accelerated assessment
Biotech | February 17, 2022

Nirsevimab EMA regulatory submission accepted under accelerated assessment

Nirsevimab is the first investigational long-acting antibody designed to protect all infants for the respiratory syncytial virus season with a single dose


Pfizer and OPKO update on the Biologics License Application for Somatrogon
Biotech | January 22, 2022

Pfizer and OPKO update on the Biologics License Application for Somatrogon

Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward


Trastuzumab deruxtecan type II variation application validated by EMA
Biotech | December 28, 2021

Trastuzumab deruxtecan type II variation application validated by EMA

Application based on DESTINY-Breast03 results showing Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan reduced risk of disease progression or death by 72% versus trastuzumab emtansine (T-DM1)


EMA approves Pfizer’s Covid-19 anti-viral candidate
News | December 17, 2021

EMA approves Pfizer’s Covid-19 anti-viral candidate

EMA’s CHMP advice states that Paxlovid can be used for treatment of adults with Covid-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease


Obseva announces U.S. FDA acceptance of new drug application for linzagolix
Biotech | November 23, 2021

Obseva announces U.S. FDA acceptance of new drug application for linzagolix

Obseva announced previously that the company has entered into a partnership with Syneos Health to support commercialization of linzagolix in the US and EU