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

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 ...

The two products, both manufactured by Amgen, are aflibercept biosimilars Pavblu and Skojoy. Both biosimilars are indicated ...

Bishop asked about upcoming events. Missling outlined the anticipated schizophrenia trial readout for ANAVEX 3-71 in the first half of 2025, the detailed ATTENTION-AD data presentation in April, and ...

the European Medicines Agency (EMA), endorsed its antibody-drug conjugate Dato-DXd marketed with AstraZeneca (NASDAQ:AZN) as a late-line option for certain cases of breast cancer. Issuing a so-cal ...

AMSTERDAM (Reuters) - The European Medicines Agency (EMA) said on Monday it would no longer post on X and would use rival Bluesky instead, becoming the latest organisation to quit a social media ...

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

The EMA anticipates that the ability to access scientific advice will foster innovation among medical device manufacturers.