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 ...

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 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 ...

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

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

Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative ...

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

Bayer seeks European approval of extended 6-month treatment interval for Eylea 8 mg to treat nAMD & diabetic macular edema: Berlin Tuesday, February 11, 2025, 10:00 Hrs [IST] Baye ...

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

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