food and drug administration

StreetInsider.com Unusual 11 Mid-Day Movers: NexMed, Inc. (Nasdaq: NEXM) 81.6% LOWER; announced that based on First Interpretable Results of Phase III clinical studies for NM100060, a topical application of terbinafine formulated with NexACT(R) for the treatment of onychomycosis, the decision has been taken not to submit a New Drug Application with the Food and Drug Administration at this time.

Cell Genesys, Inc.

(Weber Shandwick Worldwide) The Myelodysplastic Syndromes Foundation supports the decision by the US Food and Drug Administration to extend the label for vidaza to include data from the AZA-001 clinical trial.

Results from the trial found that azacitidine is the only agent which has been shown to extend survival in MDS patients.

(Weber Shandwick Worldwide) The Aplastic Anemia & MDS International Foundation is pleased to inform patients that the US Food and Drug Administration has expanded the label for Vidaza (azacitidine) to include data from the AZA-001 trial, which found that Vidaza is the only agent that extends survival in MDS (myelodysplastic syndromes) patients.

Vidaza was also shown to delay progression to acute myelogenous leukemia in patients with MDS. Roughly 30 percent of patients diagnosed with MDS will progress to AML.

(Cohn & Wolfe) GlaxoSmithKline announced today that the US Food and Drug Administration has approved KINRIX, the first combination vaccine to offer protection against diphtheria, tetanus, pertussis and polio diseases in one shot.

(Cohn & Wolfe) Data presented today on Vanda Pharmaceuticals Inc.'s investigational drug candidate, iloperidone, included its 4-week, short-term Phase III trial, as well as a pooled analysis of three long-term, 52-week trials, studying the efficacy and safety of iloperidone.

Iloperidone is a 5HT2/D2 antagonist ("atypical") antipsychotic currently under review by the US Food and Drug Administration for the treatment of schizophrenia.

The Chinese manufacturer of a heparin ingredient does not have adequate systems for ensuring that the raw materials it uses are safe and that any impurities are removed, the Food and Drug Administration told the company Monday.

The Food and Drug Administration said that recent data show patients taking H.I.V. drugs from GlaxoSmithKline and Bristol-Myers Squibb may have increased risk of heart attack.

"We've given this team the flexibility to extend this inspection as long as it takes as well as investigate the appropriate leads within China"

U.S. health officials evaluated the wrong factory when assessing the safety of a Chinese-made drug ingredient that may be a source of problems with a blood thinner, the Food and Drug Administration said Monday.

Baxter International's heparin has been linked to four deaths and hundreds of reports of allergic reactions.

An investigation will take FDA inspectors to China this week.