Xgeva (denosumab), which has already been approved by the Food and Drug Administration (FDA) for the prevention fractures in men with advanced prostate cancer that has already migrated to the bone, has been rejected by the FDA to expand the use of the drug to delay the spread of tumors in men without metastases to [...]
Historically, I have been critical of the FDA, especially around the delay of the approval of Provenge. Now, it is time to take a look at the FDA and what I believe the future will be for this agency. I do first need to make it clear that I do believe that the FDA plays [...]
Bavarian Nordic A/S (BAVA) announced on November 15, that its subsidiary, BN ImmunoTherapeutics has started the pivotal Phase 3 trial of PROSTVAC® for men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer. The trial is being conducted under a Special Protocol Assessment agreement with the FDA. Notice this trial has the same criteria as [...]
Amgen announced that the U.S. Food and Drug Administration (FDA) has approved two new indications for Prolia® (denosumab) as a treatment to increase bone mass in men receiving androgen deprivation therapy (ADT) for non-metastatic prostate cancer. Men receiving ADT are at high risk for developing fractures, including vertebral fractures, which can cause paralysis. "Bone loss [...]
A recent meeting of an FDA advisory committee has asked wants the FDA to limit the duration of bisphosphonate therapy for treatment of osteoporosis, but the committee could not agree on a time limit to recommend. […]
Amgen (NASDAQ: AMGN) today published a press release that said the U.S. Food and Drug Administration (FDA) will target an action date of April 26, 2012 for the supplemental Biologics License Application (sBLA) (approval) to expand the indication for XGEVA® (denosumab) to treat men with castrate-resistant prostate cancer with the goal of reducing the risk [...]
Amgen has submitted a supplemental Biologics License Application (sBLA) to the FDA to expand the indication for denosumab (XGEVA) its RANK ligand inhibitor to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases. If approved, denosumab would be the first therapy licensed to prevent or delay the spread of cancer [...]
Yesterday, Amgen announced that it had submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand its license for XGEVA® (denosumab) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases. If approved, XGEVA would be the first therapy licensed to prevent or [...]
There is a constant debate between both oncologist and advocates about the value and safety of 5-alpha-reductase inhibitors (Proscar and Avodart) both in the early treatment and later treatment of men with prostate cancer. In fact, I have had an on-going private debate with one very knowledgeable educator advocate over this issue. I often have [...]
Recall: Coumadin (warfarin sodium) Crystalline 5 mg Tablets - Tablets May Have Higher than Expected Potency ISSUE: Bristol-Myers Squibb initiated a voluntary recall of one lot of 1,000-count bottles of Coumadin (warfarin sodium) Crystalline 5 mg tablets. Company testing of tablets from a returned bottle found a tablet to be higher in potency than expected. [...]
