The first study was a two-part phase 1 trial in healthy adult males in China. Part 1 was an open-label pilot study, comparing HLX14’s pharmacokinetics with EU-sourced PROLIA after subcutaneous ...

If approved, donidalorsen would be a first-in-class RNA-targeted medicine for hereditary angioedema. The agency’s goal date ...

With increasing chronic diseases, demand for personalized medicines, and adoption of AI, the biotech market is booming.

Consumers need to be informed and aware of the side-effects associated with using the osteoporosis drug Prolia, says Consumers Health Forum of ...

While Amgen’s third-quarter financial results on Wednesday were “somewhat uneventful,” investors continue to be focused on ...

Denosumab stops the body breaking down bones and also removes excess calcium in the blood. “This medicine would help maintain peoples bone strength and is used to keep the calcium levels in their body ...

Organon (NYSE:OGN) and partner Shanghai Henlius Biotech said the FDA has accepted the Biologics License Application for HLX14, a biosimilar of Amgen’s (AMGN) Prolia/Xgeva, also known as denosumab.

two-arm pilot study with the primary objective to compare the PK parameters of HLX14 and EU-sourced PROLIA after subcutaneous injection to provide further basis for the study design of part 2.

Doctors acknowledge Prolia can have serious side effects ... making up more than 70 per cent of market share It's administered by injection every six months, and can't be late or skipped It ...

Part 1 was an open-label, randomized, parallel-controlled, single-dose, two-arm pilot study with the primary objective to compare the PK parameters of HLX14 and EU-sourced PROLIA after subcutaneous ...

Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the US Food and Drug Administration (FDA) has accepted the Biologic License Application (BLA) for HLX14, an ...