FDA News Articles

Company Grants License to Its Diabetes Biomarkers

Jody A. Charnow March 02, 2010

Intrinsic Bioprobes, of Tempe, Ariz.,a privately held biotechnology company, has licensed two novel biomarkers for diabetes to Ortho-Clinical Diagnostics, Inc., of Raritan, N.J.
 

Gambro Acquires Medical Device Company

Jody A. Charnow March 02, 2010

Gambro, which has its U.S. headquarters in Lakewood, Colo., has acquired CHF Solutions, a privately held medical device company in Brooklyn Park, Minn., that manufactures and distributes ultrafiltration devices to treat fluid overload, both companies announced recently.
 

Fresenius Buys the Company That Sells Acumen nEHR

Jody A. Charnow March 02, 2010

Fresenius Medical Care North America (FMCNA), headquartered in Waltham, Mass., has acquired Nashville-based Health IT Services Group and its portfolio of products, including Acumen nEHR, a nephrology-specific electronic health record.
 

Drug Cleared for Treating Moderate to Severe Rheumatoid Arthritis

Jody A. Charnow March 02, 2010

Roche has received marketing clearance for Actemra (tocilizumab) as a treatment for moderate to severe active rheumatoid arthritis (RA) in adults who have had an inadequate response to one or more treatments that block tumor necrosis factor.
 

FDA Warns Consumers about Counterfeit Weight-Loss Product

Jody A. Charnow March 02, 2010

The FDA has issued a warning to consumers about a counterfeit and possibly harmful version of Alli 60 mg capsules (120 count refill kit). Alli is an over-the-counter weight-loss product.
 

Wyeth Makes Drug Monitoring Changes for Sirolimus

Jody A. Charnow March 02, 2010

Wyeth has notified health care professionals of changes to the Rapamune (sirolimus) prescribing information related to changes in the performance of an immunoassay used for therapeutic drug monitoring (TDM) of the medication, according to the FDA.
 

Institute Is Awarded DoD Grant For Prostate Cancer Drug Research

November 19, 2009

The U.S. Department of Defense/Prostate Cancer Research Program (DoD/PCRP) has awarded a $1.55 million grant to SRI International, a nonprofit research institute based in Menlo Park, Calif., to support product-driven, preclinical studies of novel agents that have the potential to become prostate cancer drugs.
 

Lithostat for Struvite Stones Reintroduced

Jody A. Charnow November 19, 2009

Lithostat (acetohydroxamic acid), the only urease inhibitor available for urea-splitting urinary infections in association with struvite stones, is available again at pharmacies nationwide, according to the drug's marketer, Mission Pharmacal.
 

Telmisartan Okayed for Cardiovascular Risk Reduction

Jody A. Charnow November 19, 2009

Boehringer Ingelheim Pharmaceuticals has received approval for a new indication for its angiotensin II receptor blocker Micardis (telmisartan): cardiovascular risk reduction in patients aged 55 years and older who are at high risk of experiencing major cardiovascular events and are unable to take ACE inhibitors.
 

Colchicine Formulation Cleared for Preventing Gout Flares

Jody A. Charnow November 19, 2009

Colcrys, a new colchicine formulation, has received marketing clearance for the prevention of gout flares.