The FDA approves new cancer treatments in half the time of the EMA – but does faster mean better? And how can regulators balance timely access with robust safety?
Biogen has given up on seeking approval for its Alzheimer's disease therapy Aduhelm in the EU, saying that discussions with EU regulators had made it clear the current data for the drug is
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.