EMA orphan drug designation is awarded to drugs intended to treat rare diseases that are life-threatening or chronically ...

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 ...

For the first time, the European Medicines Agency has recognized AI software for the diagnosis of fatty liver hepatitis as scientifically valid. The Committee for Medicinal Products for Human Use ...

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 ...

Norgine and Theravia announced today that they have entered into a definitive agreement under which Norgine will acquire Theravia, ...

The pharmaceutical industry faces environmental challenges. Green chemistry offers sustainable solutions to reduce waste and enhance drug discovery processes.

Pharmacovigilance evolves with technology, employing active surveillance to detect drug-related issues and ensure safety in ...

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

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 ...

The European Medicines Agency (EMA) has experienced a turbulent few years. Brexit left the agency reeling, as it was forced to move from its base in London and reduce its services whilst ...