« President's FY 2010 Budget for FDA Invests Substantially in Food | Main | LeClerc Foods Announces a Limited Nationwide Voluntary Recall of Market »

FDA Approvals - BSD Receives FDA Humanitarian Use Designation for the BSD-2000 Hyperthermia


BSD Receives FDA Humanitarian Use Designation for the BSD-2000 Hyperthermia System (Business Wire via Yahoo! Finance)
SALT LAKE CITY----BSD Medical Corporation announced today that the U.S. Food and Drug Administration has granted Humanitarian Use Device designation for the company's BSD-2000 Hyperthermia System for use in conjunction with radiation therapy for the treatment of cervical carcinoma patients who are ineligible for chemotherapy.

U.S. Naval Medical Research Center Proposed 'RESUS' Clinical Trial In Trauma Patients Remains On FDA Hold (Medical News Today)
Biopure Corporation (Nasdaq: BPUR) announced that the Food and Drug Administration has advised the U.S. Naval Medical Research Center (NMRC) by letter that it may not initiate a clinical trial of Biopure's oxygen therapeutic Hemopure(R) [hemoglobin glutamer -- 250 (bovine)] under a proposed protocol submitted to the FDA in March 2009.

FDA grants approval for use of RISPERDAL CONSTA as both a monotherapy and adjunctive therapy in the maintenance ... (EurekAlert!)
( Golin/Harris International ) Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. today announced the US Food and Drug Administration has approved the Supplemental New Drug Applications for the use of RISPERDAL CONSTA (risperidone) Long-Acting Treatment as both monotherapy and adjunctive therapy to lithium or valproate in the maintenance treatment of bipolar I disorder. Bipolar I ...
 

©2006 FDA-News.com. All rights reserved.