Seeking Cures – the Road from Discoveries to Cures or the Valley of Death

It is truly amazing and very shocking, from 1996 to 1999, the U.S. food and Drug Administration (FDA) approved 157 new drugs. Compared to the period of 2006 to 2009 the FDA approved 74 drugs. However, NOT one of these approved drugs provided a cure for any serious illness! Diseases that destroy lives, diseases like [...]

US FDA Reviewing the Safety of LHRH Agonists – ADT with Advanced Prostate Cancer

Hormone therapy (ADT), using luteinizing hormone releasing hormone (LHRH) agonists or gonadatropin releasing hormone or GnRH agonists (Lupron, Zoladex, Trelstar, Viadur, Vantas, Eligard and Synarel ) have been known to have many side effects, some severe and potentially life threatening. Many of us believe that ADT is associated with cardiovascular disease and diabetes along with [...]

THE FDA HAS APPROVED PROVENGE

Provenge has finally received the long awaited approval from the FDA!!! We all celebrate and look forward to benefiting from its potential to extend our life. Provenge is the first immunologic therapy ever approved in the United States to treat cancer. (In Russia, Antigenics has received approval for an immunological treatment for kidney cancer). The [...]

No Additional Hearing at the FDA for Provenge

According to a Reuters report, a spokeswomen from the FDA said yesterday that, “There is not going to be an additional advisory committee meeting” about the current application for the approval of Provenge. The FDA has the right to convene another meeting to discuss the results of the IMPACT trial, but it now looks as [...]

Dendreon Finally Completes Its FDA Submission for the Approval of Provenge

Finally, on Monday, Dendreon announced that it completed its Food and Drug Administration (FDA) application for the approval of Provenge (sipuleucel-T). Provenge is designed as a vaccine that stimulates the body's own immune system to fight prostate cancer. It is a different type of vaccine from what most of us knows as it is given [...]

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