The EMA’s human medicines committee has said two Eli Lilly antibodies are effective in people with COVID-19 who are at risk of developing severe disease, clearing the way for use in EU member ...

to be considered for the treatment of confirmed COVID-19 CHMP scientific opinion supports national decision making within EU states on the use of the antibodies before a formal authorisation is ...

“Several EU countries have authorized bamlanivimab, and the EMA’s CHMP recommendation provides a mechanism for more EU countries to quickly access these antibodies to treat patients in need.

today announced that the European Medicines Agency (EMA) has started a review of VIR-7831 (GSK4182136), an investigational dual-action SARS-CoV-2 monoclonal antibody, for the treatment of adults ...

Recently, the European Medicines Agency (EMA) received the first marketing authorization application (MAA) for the biosimilar monoclonal antibody (mAb) infliximab 1, and the EMA's Committee for ...

announced on Monday that it has received European Medicines Agency (EMA) approval for its state-of-the-art monoclonal antibodies (mAbs) manufacturing facility in Bengaluru, India. According to a ...

"Using a detailed background on the clinical development of the first EMA approved biosimilar monoclonal antibody, this article creates a useful framework for consideration of these new drug options." ...

* EMA SAYS ALTHOUGH EMA WAS SPEEDING UP ITS REVIEW OF DATA, SOME QUESTIONS ABOUT MEDICINES' QUALITY REMAINED TO BE SATISFACTORILY ADDRESSED * EMA SAYS AT TIME OF COMPANY'S WITHDRAWAL, EMA HAD ...

was invited to participate in an FDA-EMA workshop on SARS-CoV-2 monoclonal antibodies held on December 15, 2022. Invivyd's chief scientific officer, Laura Walker, Ph.D., alongside Eli Lilly and ...

The European Medicines Agency (EMA) has agreed to review GSK’s ... If approved, the monoclonal antibody is expected to become the initial monthly-dosed biologic for COPD. GSK’s application ...

Biotechnological products are now well established as a key therapeutic modality. For example, approximately 20 therapeutic monoclonal antibodies have been approved, and more than 150 are in ...

The drug, a humanized monoclonal antibody given by intravitreal injection ... Outlook Therapeutics said that the EMA ruling on its bevacizumab-vikg formulation would be the drug's first approval ...