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 ...

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

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

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 ...

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

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

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 ...

Anavex could secure conditional approval for blarcamesine, though longer trials may be needed. Check out why AVXL stock is a ...

Stifel analysts were bullish on the data, which showed a 16.5% drop in body-mass index among patients with damage to the ...

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 ...