The ruling requires all trials across the EU to be filed through the European Medicines Agency’s digital filing system.

The reassessment of Leqembi’s safety data follows the agency’s previous recommendation of the drug for use in the EU.

The European medicines regulator said on Friday it will review safety information for Eisai and Biogen's Leqembi, nearly ...

Marketing authorization for the first EU vaccine to protect adolescents against chikungunya has been expedited for its public ...

Several medicines are poised to reach new heights after winning key endorsements from European drug regulators. | Among those ...

AstraZeneca (AZN) stock in focus as its partner Daiichi Sankyo (DSNKY) wins EU backing for their jointly developed breast ...

Bristol Myers on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of Breyanzi for the treatment of adults with relapsed or refractory ...

Merck on Friday said the recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use covers the 21-valent conjugate vaccine for immunization for the prevention ...

Bristol Myers (BMY) announced the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has ...

GSK (GSK) stock in focus as its experimental drug depemokimab undergoes EU review for asthma and nasal polyps. Read more here ...

ImmunityBio (IBRX) announced the European Medicines Agency has accepted for review and begun assessing the marketing authorization application ...

This European review of the prefilled syringe follows GSK's receipt of approval from the US Food & Drug Administration on January 8. GSK is also investigating submission of the new presentation to ...