More ‘biosimilar’ medicines should be brought to market in the EU because of a regulatory policy shift on the need to carry out expensive clinical efficacy studies, experts have said.
GSK plc GSK announced that the European Medicines Agency (“EMA”) has accepted for review a regulatory filing, seeking ...
Key regulators are not recommending Lilly’s Kisunla be cleared for the European market. The company says it plans to appeal ...
Eli Lilly's Kisunla was approved in the U.S. for Alzheimer's last year, but now advisers to the European Medicines Agency say ...
The VSTOXX Volatility Futures Index ($VSTX), which tracks the implied volatility of the EURO STOXX 50 Index, tends to exhibit ...
The EMA has recommended refusing marketing authorization for donanemab, a monoclonal antibody against amyloid beta, in the ...
A cancer patient who needed €300,000 in fundraising to have vital treatment in London has joined forces with other advocates ...
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 tool reduces pathologist variability in liver biopsy assessment during trials of treatments for metabolic ...
Crinetics (CRNX) announced that the European Medicines Agency has validated the marketing authorization application for paltusotine, the first ...