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

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

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

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

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

Fondazione Telethon, an Italian biomedical charity focused on rare genetic diseases, has submitted a Marketing Authorization ...

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

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

Ocugen (OCGN) said it has received a positive opinion from EU regulators for Advanced Therapy Medicinal Product ...

EMA approval of the Alzheimer’s disease therapy Leqembi (lecanemab) has stalled once again, after the European Commission did not as usual nod through the agency’s recommendation, but told it to ...