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The European Medicines Agency (EMA)'s pilot project will support not-for-profit organisations and academia in gathering evidence for the use of a drug in a new indication.
EMA's drug safety committee (PRAC) assessed risks with COVID-19 vaccines and identified no risk of death with Imbruvica and ACE inhibitors.
The European Medicines Agency (EMA)'s human medicines committee (CHMP) concludes that a booster dose of Spikevax can be administered in adults aged 18 or over.
The European Medicines Agency's human medicines committee (CHMP) begins its rolling review of the investigational oral antiviral molnupiravir.
The vaccine showed a relative vaccine efficacy of 95.6 percent and is the first efficacy results from a COVID-19 vaccine booster trial.
The EMA concludes that booster doses of the COVID-19 vaccines Comirnaty and Spikevax can be given to people with severely weakened immune systems.
The EMA’s drug safety committee (PRAC) assessed risks of thrombocytopenia and venous thromboembolism with the Janssen COVID-19 Vaccine.
The European Medicines Agency (EMA) is evaluating an application for the use of a booster dose of Spikevax in people aged 12 years and older.
Positive results from pivotal trial show that the COVID-19 vaccine Comirnaty is safe and effective in children aged five to 11 years old.
In its most recent meeting, the CHMP recommended nine new medicines and concluded its review of Vaxzevria’s thrombosis risk.
EMA begins evaluating the application for a booster dose of Comirnaty® in adults to be given six months after the second dose.
The EMA’s drug safety committee (PRAC) reviewed COVID-19 vaccine risks and issued a new safety signal for Imbruvica with rituximab.
The European Commission (EC) approved Ultomiris for children and adolescents with paroxysmal nocturnal haemoglobinuria (PNH).
Pfizer and BioNTech will submit a supplemental biologics licence application to the FDA for booster dose of COVID-19 Vaccine Comirnaty.
The CHMP has adopted recommendations to increase manufacturing capacity and supply of COVID-19 Vaccines Comirnaty and Moderna in Europe.
