European Medicines Agency (EMA), in close collaboration with the European Commission, has established a standard procedure ...

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

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 ...

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

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

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

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

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

GSK (GSK) announced that the European Medicines Agency, EMA, has accepted for review the Marketing Authorisation Application, MAA, for the use of depemokimab in two indications. The submitted indicati ...

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 ...

Ocugen (OCGN) announced that the European Commission has provided a positive opinion from the EMA’s, or European Medicines Agency’s, Committee ...