Celerity Pharmaceuticals uses Biocon Biologics’ insulin drug substance to develop the product
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
Recommendation is based on pivotal data from the phase III POLARIX study
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
If approved, PreHevbri will be the only approved 3-antigen hepatitis B vaccine for adults in the E.U.
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)
The medicine is the first and only oral MET inhibitor to receive CHMP positive opinion in Europe for adult patients with advanced NSCLC harbouring alterations leading to METex14 skipping
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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