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

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 ...

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

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 ...

If authorised, Vimkunya would be the first vaccine in the EU to protect adolescents aged 12 to 17 against Chikungunya.

A safety committee will review all evidence from trials and studies to shed more light on the potential risk of NAION.

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

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 ...

The European Medicines Agency (EMA), which is the regulator for vaccines and medicine in the European Union (EU), has stopped ...