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2009 NOV 23 ... to the FDA no later than in the beginning of December and subsequently will await the FDA review and acceptance hereof. Consequently, the company maintains its expectations to initiate ...
2009 NOV 23 ... Inc. (NASDAQ:CADX) announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its Priority ... (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its Priority Review of the New Drug Application (NDA) for intravenous (IV) acetaminophen by three months. ...
2009 NOV 23 ... or provide a treatment where no adequate therapy exists, and generally denotes that the FDA review period is reduced to approximately six months. ChemGenex submitted the NDA on 8 ...
2009 NOV 23 ... the advertising at issue has been referred to the Food and Drug Administration (FDA) and FTC. "Today, we call upon each company in the dietary supplement ... The Council for Responsible Nutrition (CRN) and the National Advertising Review Council (NARC) announced that they will be extending the dietary supplement advertising ...
2009 NOV 23 ... than all trans-retinoic acid (ATRA), the current first-line treatment for APL. The FDA has granted Orphan Drug Designation for APL and Fast Track Designation for the treatment ... forward to the opportunity to move this program back into the clinic," he continued. Review of Financial Results CytRx reported net income applicable to common stockholders for the ...
2009 NOV 23 ... regulatory designations and events, from Investigational New Drug (IND) filing dates to FDA 'Fast Track' and orphan drug status designations, allows subscribers to examine drug ... Development and Regulatory Analysis compares clinical development time to FDA regulatory review time to better understand how quickly companies have successfully gotten their products ...
2009 NOV 28 ... members of Congress, including Rep. Henry Waxman, D-Calif., are calling for changes to FDA regulations of DTCA. Advocates for prescription drug ads claim that these ads educate ... and portray nonmedical problems as treatable medical illnesses.In a review of the evidence for and against DTCA, Frosch and his colleagues confirm that there are ...
2009 NOV 23 ... in three separate indications. On June 1, 2009, Dyax submitted a response to the FDA's Complete Response letter regarding the review of Dyax's Biologics License ...
2009 NOV 23 ... and XenoPort, Inc. (Nasdaq: XNPT) announced that the U.S. Food and Drug Administration (FDA) has extended the original Prescription Drug User Fee Act (PDUFA) goal date for its ... (FDA) has extended the original Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) for GSK1838262/XP13512 (gabapentin enacarbil) to ...
2009 NOV 24 ... a multi-step quality assurance review that exceeds the standards set by both the FDA and American Association of Tissue Banks (AATB). Keywords: LifeNet Health, ...
2009 NOV 23 ... agreements for this product. Separately, we are still awaiting a final decision from the FDA on the pending applications for our OLpur™ H2H™ module and OLpur™ MD ... for U.S. marketing approval of these products in November 2008. Following its review of the application, the FDA requested additional information from us. Nephros replied to ...
2009 NOV 23 ... from various sources, including Pubmed, the European Medicines Agency (EMEA) and the US FDA were appraised. Tigecycline was found to be noninferior compared with levofloxacin for ... According to recent research published in the journal Expert Review of Anti - Infective Therapy, "Pneumonia, along with influenza, is the leading cause of ...
2009 NOV 23 ... effects. A modified version of the ITD is approved by the Food and Drug Administration (FDA) for use in conditions other than cardiac arrest. However, a large human ... arrest, statistics, ethics, and the conduct of clinical trials. During its interim data review on Oct. 23, the DSMB recommended stopping enrollment in both ROC PRIMED assessments ...
Subject: NIH/National Heart, Lung and Blood Institute
2009 NOV 23 ... systems, has a long-standing relationship with the U.S. Food and Drug Administration (FDA), providing ECG algorithm tools and data warehousing solutions to support regulatory ... providing ECG algorithm tools and data warehousing solutions to support regulatory review of cardiac safety data. Since 2006, FDA has been using Mortara's ECG Warehouse and ...
2009 NOV 23 ... customers and our 220-member strong specialty sales force. "In August the FDA accepted for filing our New Drug Application for rifaximin 550mg tablets for the ... hepatic encephalopathy and also announced that the NDA had been designated for Priority Review. A Priority Review classification is granted to drugs offering major advances in ...
2009 NOV 23 ... 30, 2009. Transcept previously announced that on October 28, 2009, the FDA issued a Complete Response Letter regarding the New Drug Application (NDA) for ... focus is now on moving Intermezzo=AE forward through the remainder of the regulatory review process. With $93 million of cash, cash equivalents and marketable securities at ...
2009 NOV 23 ... which is the cancer drug advisory panel of the U.S. Food and Drug Administration (FDA), voted in favor of requiring Vion to complete a randomized study defining the efficacy ... The Company may also consider financing options. The Company expects its strategic review to be completed in the fourth quarter of 2009. The outcome of the Company's strategic ...
2009 NOV 23 ... sales force. In June 2009, Xanodyne received Food and Drug Administration (FDA) approval for Zipsor, a new treatment option for relief of mild to moderate acute pain ... soon on Lysteda™ (formerly XP12B), an oral tranexamic acid compound under priority review for the potential treatment of women suffering from heavy menstrual bleeding. ...
2009 NOV 23 ... second-line setting. Patients are randomized either to doxorubicin (the only currently FDA-approved agent in sarcoma) or to palifosfamide in combination with doxorubicin. As of ... achieved the study-specified efficacy milestone following planned safety and efficacy review by the Data Committee, a panel of international sarcoma experts, and the Company's ...
2009 NOV 23 ... enrollment. The company is in dialogue with the U.S. Food and Drug Administration (FDA) on the design and implementation of a registration trial, a study the Company expects ... achieved the study-specified efficacy milestone following planned safety and efficacy review by the Data Committee, a panel of international sarcoma experts, and the Company's ...
