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

The committee reviewed data showing a 94 percent complete response rate as a third- or later-line treatment for refractory follicular lymphoma.

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

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

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

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 ...

A crackdown on the sale of counterfeit medicines online, coordinated by Europol, has resulted in the seizure of items worth ...

GSK (GSK) announced that the European Medicines Agency, EMA, has accepted for review the Marketing Authorisation Application, MAA, for the use ...

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