News

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 ...
A groundbreaking study published in the journal Current Neuropharmacology highlights a concerning potential link between Glucagon-like Peptide-1 (GLP1) receptor agonists—widely used in blockbuster ...
Raw material dependency and transport bottlenecks, not just production capacity, are the key challenges facing the EU's radiopharmaceutical sector, according to the European Medicines Agency (EMA). Vi ...
EMA orphan drug designation is awarded to drugs intended to treat rare diseases that are life-threatening or chronically debilitating < ...
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 ...
CHMP reversed its initial recommendation for the EC to not authorize the drug due to the risk of side effects like ARIA.