The pharmaceutical industry's next billion-dollar blockbuster won't come from a lab alone—it will come from listening to ...

Raw material dependency and transport bottlenecks, not just production capacity, are the key challenges facing the EU's ...

Patients are losing out on life-changing drugs for cancer and rare diseases because of Brexit, experts have warned. Treatments could be made available in the EU and US before the UK because of cost ...

Shares of Ascendis Pharma (ASND) are down $5.82, or 4%, to $155.33 in morning trading in New York. The move lower began near the open and may ...

A group of expert neurologists have expressed concerns at the European Commission’s (EC) decision to formally approve the Alzheimer’s drug lecanemab (Leqembi) despite uncertain benefits. Lecanemab, ...

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 ...

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

Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) today announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for HLX11 ...

The FDA did not agree with a supplemental Biologics License Application for the addition of extended dosing intervals of up ...

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