Food and Drug Administration News

Main Category: Sleep / Sleep Disorders / Insomnia Also Included In: Regulatory Affairs / Drug Approvals ; Clinical Trials / Drug Trials ; Pharma Industry / Biotech Industry Article Date: 24 Nov 2009 - 1:00 PST printer friendly view / write opinions rate article Transcept Pharmaceuticals, Inc.

Main Category: Cardiovascular / Cardiology Also Included In: Clinical Trials / Drug Trials ; Regulatory Affairs / Drug Approvals ; Pharma Industry / Biotech Industry Article Date: 25 Nov 2009 - 0:00 PST Evidence of cardiovascular risks associated with taking Vioxx , the popular, nonsteroidal anti-inflammatory drug , could have been identified ...

The U.S. Food and Drug Administration said Friday it has approved a new vaccine to prevent seasonal influenza.

An SPR-based method, Calibration Free Concentration Analysis can be used to accurately determine the concentration of active protein in a sample, relating to the specific binding activity of the protein, and without the need for a standard.

The U.S. Food and Drug Administration today approved Agriflu for people ages 18 years and older to prevent disease caused by influenza virus subtypes A and B. Agriflu is not intended to protect against the 2009 H1N1 influenza.

America's pharmaceutical research and biotechnology companies are testing 97 medicines and vaccines to treat or prevent HIV/AIDS and related conditions, according to a new report released by the Pharmaceutical Research and Manufacturers of America .

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. announced that the U.S. Food and Drug Administration has approved the supplemental New Drug Application for ABILIFY for the treatment of irritability associated with autistic disorder in pediatric patients ages 6 to 17 years, including symptoms of aggression towards others, deliberate ...

Some herbal supplements may boost the levels of lead in the blood of women, new research shows.

Theravance Inc. said Friday the Food and Drug Administration delayed a decision on whether to approve its infection drug Vitabiv as a treatment for hospital-acquired pneumonia.

An SPR-based method, Calibration Free Concentration Analysis can be used to accurately determine the concentration of active protein in a sample, relating to the specific binding activity of the protein, and without the need for a standard.

The American Dental Association asked the U.S. Food and Drug Administration to establish appropriate classifications for tooth-whitening chemicals.

Main Category: Swine Flu Also Included In: Immune System / Vaccines ; Clinical Trials / Drug Trials Article Date: 22 Nov 2009 - 1:00 PST Novartis announced new interim data from ongoing clinical trials demonstrating that a single 7.5 g dose of the company's influenza A 2009 unadjuvanted vaccine, half of the currently-approved US dose, fulfilled ...

Main Category: Prostate / Prostate Cancer Also Included In: Regulatory Affairs / Drug Approvals ; Clinical Trials / Drug Trials ; Pharma Industry / Biotech Industry Article Date: 21 Nov 2009 - 1:00 PST Dendreon Corporation announced that the U.S. Food and Drug Administration provided written acknowledgement that the Company's amended Biologics ...

From Associated Press PRINCETON, N.J.--The U.S. Food and Drug Administration has approved top-selling Abilify as a treatment for autism-related irritability in children from the ages of 6 to 17, drug maker Bristol-Myers Squibb Co.

Concerned over safety when used outside professional settings. The American Dental Association has asked U.S. Food and Drug Administration to establish appropriate classifications for tooth-whitening chemicals.

Sucampo Pharma Europe Ltd., a subsidiary of Sucampo Pharmaceuticals, Inc. , today announced that Swissmedic, the Swiss Agency for Therapeutic Products, has granted a marketing authorization for Amitiza 24 microgram gel capsules for the long-term treatment of patients with chronic idiopathic constipation .

The long-awaited breakthrough in women's sexual dysfunction may be here. German drugmaker Boehringer Ingelheim GmbH claims to have made a pill that will awaken female sexual desire.

ProUroCare Medical Inc. , a provider of proprietary medical imaging products, today announced that a 510 application for U.S. market clearance of a prostate mechanical imaging system has been filed with the Food & Drug Administration .

Main Category: Nutrition / Diet Also Included In: Regulatory Affairs / Drug Approvals Article Date: 25 Nov 2009 The U.S. Food and Drug Administration is seeking a permanent injunction against Sharkco Seafood International Inc., located in Venice, La.

A division of Johnson & Johnson said Wednesday that federal regulators granted full approval to an HIV drug designed to treat patients who have stopped responding to other treatments.