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.

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

The European Medicines Agency (EMA) has joined the hordes of users abandoning Elon Musk's X.com (formerly Twitter) and will ...

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

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

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

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

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 ...

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 ...