EMA establishes regular procedure for scientific advice on certain high-risk medical devices: Amsterdam, The Netherlands Wednesday, February 12, 2025, 13:00 Hrs [IST] EMA, in clos ...

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

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

In looking across the past four years of regulatory decisions, we noticed that some of the analyses involving the European Medicines Agency (EMA)'s cycle time used an inappropriate endpoint ...

The European Medicines Agency (EMA) has recommended granting marketing authorization for the pneumococcal vaccine Capvaxive ...

In the latest development, the European Commission has asked the EMA's human medicines committee, the CHMP, to take a look at ...

Berlin: Bayer has submitted an application to the European Medicines Agency (EMA) to expand treatment intervals of up to 6 ...

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

Telethon Foundation is seeking approval for a gene therapy to treat the rare disease Wiskott-Aldrich syndrome.

CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars:  On January 30, 2025, the European Medicines Agency (EMA) Committee ...