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 said Wednesday that it had given formal approval for Leqembi, a long-awaited new treatment for ...

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 ...

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

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 ...

AptarGroup is poised for growth in its Pharma and Closure segments, but challenges are expected in the Beauty segment. See ...

One in 10 medical products circulating in low—and middle-income countries (LMICs) is substandard or fake, with the majority ...

The European Space Agency has kicked off a competition to support the development of new launch vehicles and boost Europe's access to space. The agency issued the call for proposals for the ...

Business Wire IndiaShanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) today announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) ...

Organon’s diverse portfolio offers over 70 medicines and products in women’s health, biosimilars, and a large franchise of established medicines across a range of therapeutic areas.