Posted on May 16, 2020 by Sitemaster
Yesterday evening the US Food and Drug Administration (FDA) approved rucaparib (Rubraca) for the treatment of men with BRCA1/2-mutant, metastatic, castration-resistant prostate cancer (mCRPC) who have also already been treated with androgen receptor-directed therapy and taxane-based chemotherapy. … READ MORE …
Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment | Tagged: approval, castration-resistant, FDA, inhibitor, mCRPC, metastatic, PARP, Rubraca, rucaparib | 1 Comment »
Posted on June 9, 2019 by Sitemaster
At the end of May, just prior to the annual meeting of ASCO, the US Food and Drug Administration (FDA) granted fast track designation to an investigational agent called ARV-110 for treatment of metastatic, castration-resistant prostate cancer (mCRPC). … -READ MORE …
Filed under: Drugs in development | Tagged: ARV-110, castration-resistant, fast, FDA, mCRPC, metastatic, track | Leave a comment »
Posted on August 13, 2018 by Sitemaster
A newly published review by staff of the Center for Devices and Radiological Health (CDRH at the U.S. Food & Drug Administration (FD) addresses the potential role for patient preference information (PPI) in determining patient perceptions of the “value” of high-intensity focused ultrasound (HIFU) and similar techniques in the management of prostate cancer. … READ MORE …
Filed under: Living with Prostate Cancer, Management, Treatment | Tagged: approval, benefit, devices, FDA, HIFU, information, medical, patient, preference, risk | Leave a comment »
Posted on May 24, 2017 by Sitemaster
Yesterday, the US Food & Drug Administration (FDA) did something it has never done before. It approved a drug for the treatment of a type of cancer based exclusively on the presence of a specific biomarker — with no reference to the location of the cancer in the patient’s body. … READ MORE …
Filed under: Drugs in development | Tagged: approval, biomarker, FDA, pembrolizumab | 8 Comments »
Posted on May 23, 2017 by Sitemaster
In January this year we had mentioned that a company called Churchill Pharmaceuticals was developing a new “submicron” formulation of abiraterone acetate. … READ MORE …
Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment | Tagged: abirateone, acetate, Churchill, FDA, Yonsa | 3 Comments »
Posted on February 24, 2016 by Sitemaster
The “New” Prostate Cancer InfoLink is extremely pleased to see that, earlier today, the U.S. Senate has confirmed Dr. Robert Califf as the new Commissioner of the U.S. Food and Drug Administration (FDA), as a successor to Dr. Margaret Hamburg. … READ MORE …
Filed under: Uncategorized | Tagged: Califf, FDA | 4 Comments »
Posted on February 3, 2016 by Sitemaster
For those able to access the February 2016 issue of the AUA News, it carries an interesting article outlining the U.S. Food and Drug Administration’s perspective on exactly why the agency decided to approve two forms of high-intensity focused ultrasound (HIFU) technology for the transrectal ablation of prostate tissue. … READ MORE …
Filed under: Management, Treatment | Tagged: approval, FDA, focuse, HIFU, high-intensity, ultrasound | 3 Comments »
Posted on October 15, 2015 by Sitemaster
The U.S. Food & Drug Administration has now posted, on its web site, the approval letter issued to SonaCare Medical with reference to the approval to market the company’s Sonablate® 450 technology. … READ MORE …
Filed under: Treatment | Tagged: approval, FDA, HIFU, process, regulatory, Sonablate | 40 Comments »
Posted on November 5, 2014 by Sitemaster
Filed under: Uncategorized | Tagged: FDA, input ideas, patient | Leave a comment »
Posted on August 6, 2014 by Sitemaster
In a second statement to the media since an advisory panel to the U.S. Food and Drug Administration (FDA) decided not to recommend approval of EDAP TMS’s outdated form of Ablatherm technology for the treatment of low-risk prostate cancer, the company’s CEO seems to exhibit serious misunderstandings about how to work with the FDA. … READ MORE …
Filed under: Diagnosis, Management, Risk, Treatment | Tagged: Ablatherm, approval, FDA, HIFU, high-intensity focused ultrasound | 22 Comments »
Posted on July 31, 2014 by Sitemaster
In an entirely unsurprising result yesterday, an advisory committee to the U.S. Food and Drug Administration (FDA) voted very clearly against the approval of EDAP TMS’s Ablatherm technology for treatment of low-risk, localized prostate cancer using high-intensity focused ultrasound (HIFU). … READ MORE …
Filed under: Management, Treatment | Tagged: Ablatherm, FDA, focused, HIFU, high-intensity, Sonablate, ultrasound | 29 Comments »
Posted on January 10, 2014 by Sitemaster
A new article in Clinical Cancer Research offers us insights into the US Food and Drug Administration’s thinking about the approval of abiraterone acetate for the treatment of chemotherapy-naive patients with metastatic, castration-resistant prostate cancer (mCRPC). … READ MORE …
Filed under: Drugs in development, Living with Prostate Cancer, Management | Tagged: abiraterone, endpoint, FDA, progression, radiographic, survival | 1 Comment »
Posted on June 28, 2013 by Sitemaster
Working in association with the U.S. Department of Justice and INTERPOL, the U.S. Food and Drug Administration (FDA) has just managed to shut down nearly 1,700 illegal pharmacy web sites and confiscate some $40 million worth of illegal medicines. So … READ MORE …
Filed under: Uncategorized | Tagged: FDA, on-line, pharmacy | 4 Comments »
Posted on March 1, 2013 by Sitemaster
According to an on-line report in the Financial Times published late last night, “The FDA has received an increase in reports of problems associated with [Intuitive’s da Vinci robotic surgical technology] and said it is trying to weigh the risks and benefits of using robotic surgery rather than conventional surgery.” … READ MORE …
Filed under: Uncategorized | Tagged: da Vinci, FDA, problem, robot | 2 Comments »
Posted on February 13, 2013 by Sitemaster
The U.S. Food and Drug Administration (FDA) has granted a priority review for radium-223 dichloride in the treatment of men with castration-resistant prostate cancer (CRPC) and bone metastases. … READ MORE …
Filed under: Living with Prostate Cancer, Management, Treatment | Tagged: FDA, NDA, radium-223 | Leave a comment »
THE "NEW" PROSTATE CANCER INFOLINK 