The approval follows the positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in October 2022
Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints
If approved, TAK-003 has the potential to become an important dengue prevention option for healthcare providers
Kauliv provides reusable and disposable pen2 device options to cater to the global market demand.
First and only next-generation protein-based adjuvanted COVID-19 booster approved in Europe
First and only biologic approved in the EU in patients with severe asthma with no phenotype or biomarker limitations
Tabrecta is the number one prescribed targeted therapy for advanced NSCLC with alterations leading to METex14 skipping globally
Approval follows CHMP recommendation for use in patients previously vaccinated with Vaxzevria or an EU-approved mRNA Covid-19 vaccine
Heavy bleeding after giving birth is globally a leading cause of death in new mothers
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
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