BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Medicines Agency (EMA) has granted PRIority MEdicines (PRIME) designation to ...

These guidelines help ensure that products are fit for their intended use and comply with applicable regulatory standards.

The approval is supported by strong preclinical data demonstrating MP1032's capacity to sustain muscle function.

Global regulatory advancements in biosimilars enhance access to affordable treatments for autoimmune disorders, bone diseases ...

CHMP has advised that Alhemo be approved for people with severe hemophilia A and moderate or severe hemophilia B without inhibitors.

It has been a tumultuous two weeks for Sarepta; however, the FDA reauthorising US shipments of Elevidys will be a welcome ...

PTC Therapeutics Inc. will be launching its oral phenylketonuria therapy, Sephience (sepiapterin) in both the U.S. and Europe this summer, following the U.S. FDA approval just ahead of its July 29 ...

The drug targets the overgrowth of synovial cells and inflammatory components that drive tumor development and joint ...

David King of Samsung Biologics shares insights on market demand and the technologies and capabilities needed to support ...

FDA probes Elevidys after an 8-year-old's death in Brazil; Sarepta and Roche say the death was unrelated to gene therapy ...