The European Commission on Tuesday authorized the use of Eisai and Biogen's drug to treat some patients with mild cognitive impairment in the early stages of Alzheimer's disease, ending a more than ...

Eisai and Biogen can finally put their European regulatory uncertainty surrounding Alzheimer's disease medicine Leqembi ...

Cullinan Therapeutics (CGEM) announced that the European Medicines Agency, EMA, approved the Company’s Clinical Trial Application, CTA, for ...

SHANGHAI, China & JERSEY CITY, N.J., March 28, 2025--(BUSINESS WIRE)--Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) today announced that the European Medicines Agency (EMA ...

On April 1, 2025, the European Medicines Agency opened the consultation period for its draft reflection paper on a tailored clinical approach ...

EMA orphan drug designation is awarded to drugs intended to treat rare diseases that are life-threatening or chronically ...

Crofelemer, a novel plant-based anti-secretory prescription drug, has been granted Orphan Drug Designation by the FDA and the European Medicines Agency (EMA) for both short bowel syndrome (SBS) and mi ...

The European Commission (EC) and the Medicines and Healthcare products Regulatory Agency (MHRA) have approved sugemalimab in combination with platinum-based chemotherapy for the first-line ...

CHMP reversed its initial recommendation for the EC to not authorize the drug due to the risk of side effects like ARIA.

SHANGHAI, China & JERSEY CITY, N.J.--(BUSINESS WIRE)--Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) today announced that the European Medicines Agency (EMA) has validated the ...