It is too early to consider widespread use of a second COVID-19 vaccine booster dose, according to the European Centre for Disease Prevention and Control (ECDC) and EMA's COVID-19 task forc
The European Commission, EMA and national regulators within the EU have launched an initiative to change the way clinical trials are designed and run in order to position the bloc as an int
The EMA's human medicines committee has said it cannot approve Biogen and Eisai's Alzheimer's disease therapy Aduhelm, saying it was unconvinced by the data submitted for the drug.
Biogen and Eisai have said that the EMA's human medicines committee looks unlikely recommended approval of their Alzheimer's drug Aduhelm when it comes up for discussion next month.
The EMA has started its review of AstraZeneca and Daiichi Sankyo's Enhertu for a second indication, as a second-line treatment for HER2-positive gastric cancer.
The EMA has started a rolling review of Merck & Co and Ridgeback Biotherapeutics' much-anticipated oral antiviral molnupiravir as a treatment for COVID-19 in adults.
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