Content about Denosumab

June 13, 2013

The Food and Drug Administration has approved a drug made by Amgen for treating a rare and usually noncancerous bone tumor, the agency said Thursday.

SILVER SPRING, Md. – The Food and Drug Administration has approved a drug made by Amgen for treating a rare and usually noncancerous bone tumor, the agency said Thursday.

September 21, 2012

The Food and Drug Administration has approved a new usage for an Amgen drug, the drug maker said.

THOUSAND OAKS, Calif. — The Food and Drug Administration has approved a new usage for an Amgen drug, the drug maker said.

The biotech manufacturer announced the FDA approval of Prolia (denosumab) to increase bone mass in men with osteoporosis who are at high risk for fracture. The drug already was approved for osteoporosis in postmenopausal women.

November 21, 2011

A drug made by Amgen delayed the spread of prostate cancer to the bones in men with the disease and prolonged the survival of men with the condition, according to results of a late-stage clinical trial.

THOUSAND OAKS, Calif. — A drug made by Amgen delayed the spread of prostate cancer to the bones in men with the disease and prolonged the survival of men with the condition, according to results of a late-stage clinical trial.

October 11, 2011

The Food and Drug Administration has approved Mylan’s promethazine hydrochloride tablets, a generic drug for treating allergies, in the 12.5-mg, 25-mg and 50-mg strengths.

SUPPLIER NEWS — The Food and Drug Administration has approved Mylan’s promethazine hydrochloride tablets, a generic drug for treating allergies, in the 12.5-mg, 25-mg and 50-mg strengths. Promethazine hydrochloride tablets, which are manufactured by several companies, had sales of about $42 million during the 12-month period ended in June, according to IMS Health.


September 19, 2011

The Food and Drug Administration has approved two new uses for a drug made by Amgen, the drug maker said Monday.

THOUSAND OAKS, Calif. — The Food and Drug Administration has approved two new uses for a drug made by Amgen, the drug maker said Monday.

Amgen announced the approval of the biotech drug Prolia (denosumab) for increasing bone mass in men and women who are at risk of fractures due to hormone ablation treatments they are receiving for prostate and breast cancer, respectively.

August 23, 2011

The Food and Drug Administration will decide whether or not to approve a new usage for a cancer drug made by Amgen by next year, the drug maker said.

THOUSAND OAKS, Calif. — The Food and Drug Administration will decide whether or not to approve a new usage for a cancer drug made by Amgen by next year, the drug maker said.

December 13, 2010

A drug made by Amgen was able to delay certain bone problems in patients with advanced breast cancer better than a competing drug, according to study results presented at the 33rd annual San Antonio Breast Cancer Symposium.

THOUSAND OAKS, Calif. — A drug made by Amgen was able to delay certain bone problems in patients with advanced breast cancer better than a competing drug, according to study results presented at the 33rd annual San Antonio Breast Cancer Symposium.

Amgen said Xgeva (denosumab) was able to delay weakness and fracturing resulting from the cancer spreading to the bones five months longer than Novartis’ Zometa (zoledronic acid).

The Food and Drug Administration approved Xgeva on Nov. 18.

November 18, 2010

The Food and Drug Administration has approved a treatment for preventing skeletal injuries in patients...

SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment for preventing skeletal injuries in patients whose cancer has spread to the bone.

 

The FDA announced Friday the approval of Thousand Oaks, Calif.-based biotech company Amgen’s Xgeva (denosumab) for bone metastases.

 

 

November 4, 2010

Biotech company Amgen took home a top award for one of its drugs at an...

THOUSAND OAKS, Calif. Biotech company Amgen took home a top award for one of its drugs at an annual event for drug makers, the company said Friday.

 

Amgen won the Best New Drug award for the osteoporosis treatment Prolia (denosumab) at the 2010 Scrip Awards in London Thursday.

 

The drug works by targeting the cells that break down bone, called osteoclasts, and was named one of the top 10 medical breakthroughs of 2009 in Time magazine.

July 18, 2010

The Food and Drug Administration has given priority review to an application from Amgen for...

June 1, 2010

The Food and Drug Administration has approved a new drug from Amgen for osteoporosis, Amgen...

May 18, 2010

Amgen has submitted a regulatory approval application to the Food and Drug Administration for a...

February 8, 2010

An investigational drug made by Amgen for treating prostate cancer that had spread to the...