What FDA drug approval does and does not mean

If you are among the people in America who agree with one or other of the following two statements, you need an immediate crash course in what approval of a new drug by the U.S. Food & Drug Administration (FDA) does actually mean: … READ MORE …

AUA comments on FDA guidance on safe use of 5-ARIs

The American Urological Association (AUA) has written to the U.S. Food & Drug Administration (FDA) seeking modification of the FDA’s recent guidance on the use of 5α-reductase inhibitors like dutasteride and finasteride in the management of urologic conditions. … READ MORE …

FDA does a pretty good job of approving new drugs to treat cancer

It is common to hear people complain that the U.S. Food & Drug Administration (FDA) takes too long to approve new cancer therapies or that new drugs are brought to market much sooner in Europe than they are in America. A new and independent assessment of the facts actually suggests quite the opposite. … READ MORE …

FDA publishes analysis of decision not to approve 5-ARIs for prostate cancer prevention

The “New” Prostate Cancer InfoLink is delighted to see Dr. Pazdur and colleagues from the U.S. Food & Drug Administration (FDA) present their reasoning for non-approval of the 5α-reductase inhibitors (5-ARIs) dutasteride and finasteride for prevention of prostate cancer in a new article in the New England Journal of Medicine. … READ MORE …

5α-Reductase inhibitors and risk for high-grade prostate cancer

Yesterday the US Food & Drug Administration (FDA) updated its guidance on the use of 5α-reductase inhibitors with specific reference to the risk that use of these products may be able to induce high-grade (and therefore high-risk) prostate cancer in a small subset of men treated with these agents. … READ MORE …

“The FDA-pharmaceutical industry complex”

Some readers of The “New” Prostate Cancer InfoLink will be interested in a new article with the above title by Prof. Emil Freireich, MD, that appears in the most recent issue of The ASCO Post. Professor Freireich’s opinion is certainly stimulating, although the problem as described and the solution as proposed may not be quite as straightforward as suggested.

FDA says no to dutasteride for prostate cancer prevention

Based on the 14 to 2 “against” vote of an Oncology Drugs Advisory Committee meeting late last year, the U.S. Food & Drug Administration has rejected the application to approve dutasteride (Avodart) for prevention of prostate cancer in men at potentially elevated risk for a future postive biopsy. … READ MORE …

Will the FDA be approving ipilimumab relatively soon?

Apparently the U.S. Food & Drug Administration (FDA) has canceled a  meeting of the Oncology Drugs Advisory Committee (ODAC) that had been scheduled for February 9. The meeting was originally intended to discuss issues related to a biologics license application for ipilimumab (trade name Yervoy™). … READ MORE …

Amgen files new drug application for denosumab

According to a company media release issued last Friday, Amgen has filed a second new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for approval of denosumab (a RANK-L inhibitor to be known commercially as Prolia®). … READ MORE …