FDA - malecare.org

Great News for the Advanced Prostate Cancer Community – The FDA Grants a Priority Review for Radium-223 Dichloride (Alpharadin)

Some more good news for the advanced prostate cancer community was announced today. Bayer HealthCare announced that the U.S. Food and Drug Administration (FDA) has granted priority review to their New Drug Application (NDA) filed in December 2012 for the investigational oncology compound radium-223 dichloride (radium-223). The application is under review for the treatment of [...]

By Malecare|2020-02-04T08:22:15-05:00February 13th, 2013|Advanced Prostate Cancer, Alpharadin (radium-223), Clinical Trials, Clinical Trials, FDA, General Information, Uncategorized|0 Comments

Dr. Sartor Announces Bayer has Requested FDA Approval of Alpharedin & He Will Join Malecare to Make a Pod Cast Upon its Approval

On Thursday evening I had the opportunity to meet Dr. Oliver Sartor from the University of Tulane. At that time he informed me that Bayer had finally submitted the required paperwork to the FDA for formal approval of radium-233 chloride. For those of you who are not familiar with Dr. Sartor, he is both an [...]

By Malecare|2012-12-17T09:18:40-05:00December 17th, 2012|Advanced Prostate Cancer, Alpharadin (radium-223), Bone Metastases, Clinical Trials, Clinical Trials, Drugs & Treatments, Early/Expanded Access Programs, FDA, On The Horizon, Radiotherapy, Uncategorized, Understanding APC|2 Comments

Some Good Morning News, Zytiga Approved by the FDA for Earlier Use

Some mornings we just wake up to great news and today is one of those mornings. The Food and Drug Administration (FDA) has just announced that they have approved Zytiga (abiraterone acetate) for use prior to chemotherapy. - This FDA announcement is an expansion of their prior approved (April 2011) for the use of Zytiga [...]

By Malecare|2017-10-19T10:50:28-04:00December 11th, 2012|abiraterone acetate, Advanced Prostate Cancer, Chemo Therapy, Chemo Therapy Failure, Drugs & Treatments, FDA, General Information, Uncategorized, Understanding APC, Zytiga|0 Comments

Safety Plan for (ESAs) Used to Treat Chemotherapy-Related Anemia

One of the more common side effects of chemotherapy is anemia, or the lack of hemoglobin (red blood cells). Severe anemia is dangerous and will require the suspension of the use of chemotherapy as well as immediate treatment. In light of this the U.S. Food and Drug Administration (FDA) has required that Amgen Inc. developed [...]

By Malecare|2020-02-04T11:16:10-05:00October 9th, 2012|Advanced Prostate Cancer, Chemo Therapy, Drugs & Treatments, FDA, General Information, Uncategorized, Understanding APC|0 Comments

How To Dispose of Unneeded Medications

We all manage to accumulate prescription and non-prescription medications that we no longer need. They can sit in our medicine chests accumulating dust or even be stolen and sold for illegal use. Some people just throw them away in their garbage cans and others flush them down the toilet. Al three of these solutions are [...]

By Malecare|2020-02-04T11:27:56-05:00September 25th, 2012|Advanced Prostate Cancer, Drugs & Treatments, FDA, General Information, How We Live, Uncategorized|0 Comments