Arbios Granted FDA Allowance to Expand SEPET(TM) Clinical Trial Eligibility
Arbios Granted FDA Allowance to Expand SEPET(TM) Clinical Trial Eligibility (FinanzNachrichten)
WALTHAM, Mass., Sept. 29 /PRNewswire-FirstCall/ -- Arbios Systems, ( Nachrichten ) Inc. announced today that the U.S. Food&Drug Administration (FDA) has allowed expansion of the eligibility criteria for the ongoing clinical trial of its SEPET(TM) Liver Assist Device to include patients with hepatic encephalopathy due to combined liver and kidney (renal) failure.
Matritech Notified by AMEX of Continued Listing Standards Non-Compliance (Business Wire via Yahoo! Finance)
NEWTON, Mass.----Matritech , a leading marketer and developer of protein-based diagnostic products for the early detection of cancer, today reported that on September 21, 2006 it received a letter from the American Stock Exchange stating that AMEX has determined that the Company is not in compliance with certain continued listing standards including Section 1003 of the Company Guide with
Axcan Receives FDA Approval Letter for PYLERA'TM' -Formerly Known as HELIZIDE-, an Innovative 3-in-1 Capsule Triple (Market Wire via Yahoo! Finance)
Axcan Pharma Inc.(NASDAQ: AXCA) today announced that the US Food and Drug Administration has issued an approval letter for the Company's New Drug Application for PYLERA(TM). PYLERA(TM) is a patented 3-in-1 capsule triple therapy, for the eradication of Helicobacter pylori, which is a bacterium now recognized as being the main cause of gastric and duodenal ulcers.