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

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 ESMP is integrated with the European Medicines Agency’s (EMA) data management services to ensure a reliable exchange of information. The upcoming second version will enable MAHs and NCAs to ...

Mitsubishi Tanabe Pharma has withdrawn its EU application for ALS drug Radicava (edaravone), citing ‘unwarranted’ additional data requirements from the EMA. The drug has been approved in the ...

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

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

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

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 ...

Please note that, in November 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion recommending marketing approval for ...