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
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
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 is the first investigational long-acting antibody designed to protect all infants for the respiratory syncytial virus season with a single dose
Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward
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’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
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