The EMA has recommended refusing marketing authorization for donanemab, a monoclonal antibody against amyloid beta, in the ...

A European regulatory committee has rejected Eli Lilly’s U.S.-approved Alzheimer’s disease treatment over potentially ...

The benefits of naltrexone/bupropion (Mysimba) continue to outweigh its risks, despite ongoing uncertainty about long-term ...

Novo Nordisk (NVO) stock dropped on Monday despite the drugmaker reporting positive results for its GLP-1 medicine, Rybelsus.

Mizuho says that while “any clinical hold is concerning,” the European Medicines Agency’s request to pause the three Elevidys studies will ...

In response to a request from the European Medicines Agency (EMA) following the death of a 16-year-old patient in the U.S., ...

Sarepta Therapeutics, Inc. (NASDAQ:SRPT) shared an update on Elevidys (delandistrogene moxeparvovec-rokl), the only approved ...

President Trump yesterday announced a baseline tariff of 10% on all imported products and higher rates on certain countries ...

Amid a raft of federal changes cutting funding and capacities at the Food and Drug Administration, investors are soon ...

The European Medicines Agency (EMA) announced it is exploring improvements to the development and evaluation of biosimilar ...

Eli Lilly's Alzheimer's treatment is approved for use in the U.S. but the European Medicines Agency recommended against the ...

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 ...