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.

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

The European Medicines Agency (EMA) said on Monday it would no longer post on X and would use rival Bluesky instead, becoming ...

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

The global health landscape faces challenges and innovations, with the European review of Alzheimer's drug Leqembi, Ebola ...

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 ...

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

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

Merck (MRK) announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, recommended ...

Biogen (BIIB) stock in focus as company and partner Eisai (ESALF) face delay in the EU launch of Alzheimer's drug lecanemab.