Denosumab News and Research

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Denosumab is a fully human monoclonal antibody that targets RANK Ligand and is being investigated for its potential to prevent and treat a broad range of bone disease conditions including osteoporosis, bone metastases and their consequences, cancer treatment-induced bone loss due to hormone ablative therapy, multiple myeloma and bone erosions in rheumatoid arthritis. Denosumab is the first late-stage investigational therapy that specifically inhibits RANK Ligand, an essential mediator of the cells that break down bone.
Amgen second-quarter total revenue increases 2% to $3,804 million

Amgen second-quarter total revenue increases 2% to $3,804 million

Amgen granted FDA priority review designation for denosumab BLA

Amgen granted FDA priority review designation for denosumab BLA

Phase 3 trial demonstrates superiority of Amgen's denosumab over Zometa in preventing SREs

Phase 3 trial demonstrates superiority of Amgen's denosumab over Zometa in preventing SREs

Positive results from new analyses of denosumab Phase 3 trials

Positive results from new analyses of denosumab Phase 3 trials

Amgen's Prolia receives FDA approval for treatment of postmenopausal women with osteoporosis

Amgen's Prolia receives FDA approval for treatment of postmenopausal women with osteoporosis

Amgen announces European approval of Prolia

Amgen announces European approval of Prolia

Halozyme Therapeutics announces delivery of notice of breach to Baxter Healthcare

Halozyme Therapeutics announces delivery of notice of breach to Baxter Healthcare

No increase in risk of glioma or meningioma with use of mobile phones: INTERPHONE project

No increase in risk of glioma or meningioma with use of mobile phones: INTERPHONE project

Amgen submits BLA for denosumab subcutaneous RANK Ligand inhibitor

Amgen submits BLA for denosumab subcutaneous RANK Ligand inhibitor

U.S. healthcare practitioners can resume use of Rotarix, says FDA

U.S. healthcare practitioners can resume use of Rotarix, says FDA

FDA assigns Cadence Pharmaceuticals' OFIRMEV NDA new PDUFA action date

FDA assigns Cadence Pharmaceuticals' OFIRMEV NDA new PDUFA action date

RANKL inhibition may prove effective in treatment of human malignancy, suggests study

RANKL inhibition may prove effective in treatment of human malignancy, suggests study

Amgen's Prolia Complete Response submission: FDA classifies and sets PDUFA date

Amgen's Prolia Complete Response submission: FDA classifies and sets PDUFA date

Denosumab exhibits superiority over Zometa in treatment of prostate cancer men with bone metastases

Denosumab exhibits superiority over Zometa in treatment of prostate cancer men with bone metastases

European CHMP announces positive opinion for Amgen's Prolia marketing authorization

European CHMP announces positive opinion for Amgen's Prolia marketing authorization

New data suggests bisphosphonate drug may play a role in reducing recurrent breast cancer

New data suggests bisphosphonate drug may play a role in reducing recurrent breast cancer

Amgen receives Complete Response Letter for the Biologic License Applications for Prolia from FDA

Amgen receives Complete Response Letter for the Biologic License Applications for Prolia from FDA

Amgen announces results of Phase 3 head-to-head trial evaluating denosumab versus Zometa

Amgen announces results of Phase 3 head-to-head trial evaluating denosumab versus Zometa

Amgen announces results of Phase 3 trial in the treatment of bone metastases

Amgen announces results of Phase 3 trial in the treatment of bone metastases

Amgen to present its four Phase 3 clinical trial results

Amgen to present its four Phase 3 clinical trial results