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EMA

The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).

Discovery and Development

А phase III study proven the efficacy of the bevacizumab biosimilar in patients with late stages of NSCLC

Techno -
New results for Phase III study of BCD-021, a bevacizumab biosimilar, were presented as a poster at the European Society for Medical Oncology (ESMO)...
Newsletter

EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty

Techno -
EMA has started evaluating an application for the use of a booster dose of Comirnaty to be given 6 months after the second dose...
Regulatory News

Comirnaty and Spikevax: possible link to very rare cases of myocarditis and pericarditis

Techno -
At this point in time, no causal relationship with myocarditis or pericarditis could be established with two other COVID-19 vaccines authorised in the EEA, COVID-19 Vaccine Janssen and Vaxzevria.
Regulatory News

The European Parliament proposed to expand the powers of the EMA

Techno -
Parliament wants to strengthen the transparency of both the Agency and all actors in the supply chain, and give a more active role to healthcare professionals, as well as encouraging synergies between EU agencies.
World Pharma News

EMA approves new site for manufacture of Moderna Covid-19 vaccine in France

Techno -
The European Medicines Agency (EMA) announced on June 11, 2021 that its committee for human medicines (CHMP) has approved a new manufacturing site for the...
Regulatory News

Vaxzevria: EMA advises against use in people with history of capillary leak syndrome

Techno -
EMA’s safety committee (PRAC) has concluded that people who have previously had capillary leak syndrome must not be vaccinated with Vaxzevria (formerly COVID-19 Vaccine...
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Expert Articles

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