The study found that just 20% of trials submitted to both the FDA and European Medicines Agency had matching evidence.

A false claim is circulating online that the European Medicines Agency (EMA) has acknowledged that mRNA vaccines have not ...

The European Union's medicines regulator on Friday reiterated its positive recommendation for Eisai and Biogen's Alzheimer's ...

Pfizer's Covid-19 vaccine is considered by healthcare authorities to be safe and effective, with data gathered from billions ...

of the European Medicines Agency (EMA) has adopted a positive opinion recommending authorization of a label extension for IXCHIQ ®, Valneva’s single-dose vaccine for the prevention of disease caused ...

The European orphan drug market is growing and is already comparable in size and scope to the US market. The European Union ...

Orphelia Pharma is exploring alternative regulatory pathways for KIZFIZO after receiving a negative opinion from the ...

Eisai (ESAIY) and Biogen (BIIB) announced that the Committee for Medicinal Products for Human Use, CHMP, of the European Medicines Agency, EMA, ...

The EMA is implementing major changes to accelerate drug approvals in the EU, addressing delays that affect patients and businesses alike. Following a turbulent period marked by Brexit and the ...