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Anthrax test, developed by army and CDC, receives FDA approval

A method for identifying Bacillus anthracis, the causative agent of anthrax, has been cleared for diagnostic use by the U.S. Food and Drug Administration (FDA). The test, known as the Gamma Phage Assay, was modified by scientists at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) to improve its performance and reliability when used with clinical specimens. The original...

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Third Wave seeks approval of Cystic Fibrosis test

The test product, which Third Wave calls InPlex, is a genotyping test to determine Cystic Fibrosi...

Kyron wins FDA approval for brain imaging technology

Approval from the Kyron C...

SGI receives court approval for bankruptcy motions

The approval came during a hearing in which the U.S. Bankruptcy Court for the Southern District of New York granted approval o...

FDA programs encourage and expedite drug development and approval

Nearly half of all products produced by biotech companies are for orphan diseases. Two of the large...

UW-Stevens Point Professor Receives Patent Approval For New Technology

Stevens Point, Wis. The University of Wisconsin-Stevens Point will receive the second patent in the universitys history. The , an organization that manages intellectual property apart from UW-Madison, has received notice from the U.S. Patent and Trade Office that a patent will soon be issued for a UW-Stevens P...

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Ranbaxy gets US FDA approval for Lisinopril

Ranbaxy Pharmaceuticals Inc (RPI) has received a tentative approval from the US FDA for Lisinopril tablets. Lisinopril is recommended for hypertension, either alone for initial therapy or with other classes of anti-hypertenive agents. It is also used as adjunctive therapy in the management of heart failure and patients who do not respond to diuretics. // However it expects to launch...

Approval for DNA test to detect cystic fibrosis

Food and Drug Administration (FDA) of US had approved the first test that// uses DNA in blood to diagnose cystic fibrosis. The test is called Tag-It Cystic Fibrosis Kit and it can analyze DNA samples from the blood and detect genes that carry the strains of the disease, both in children and in adults. The test can not only predict the advent of the disease in people, but it can also id...

Aurobindo gets U.S. FDA approval for Cephalexin

Aurobindo Pharma Ltd has announced that U.S. Food Drug Administration (US FDA) has approved its Cephalexin capsules USP 250 mg & 500 mg.// Cephalexin is used to treat many different types of bacterial infections such as bronchitis, tonsillitis, ear infections, skin infections, and urinary tract infections.The company has achieved another major milestone by obtaining the first product...

Cadila gets US FDA approval for Promethazine tablets

Cadila Healthcare Ltd has received US Food Drug Administration (US FDA) approval to market Promethazine tablets 12.5 mg, 25 mg and 50 mg in the US.// Promethazine is an anti-emetic drug, used to treat allergic symptoms and reactions, to cause sedation, to assist in controlling postoperative pain and to control motion sickness. The company plans to launch the drug in US this ye...

Vaccine For Cervical Cancer Awaits Approval

Sanofi Pasteur MSD is in the process of developing a vaccine called Gardasil against cervical cancer. The regulatory approval for the new vaccine is being sought by the organization in Europe and the US.// The European Medicines Agency for Sanofi Pasteur MSD has to approve of the marketing authorization for selling the product in Europe. Gardasil is reported to have a decided advantage...

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Approva at Medicine Products

Cystic Fibrosis 3199del6 Only(ARUP Medical Director or Genetic Counselor approval required prior to testing)

Description:ARUP Laboratories is a national reference laboratory and a worldwide leader in innovative laboratory research and development. ARUP offers an extensive test menu of highly complex and unique medical tests in clinical and anatomic pathology. Owned by the University of Utah, ARUP Laboratories' clients include more than half of the nation's university teaching hospitals and children's hospitals, maj...
Company:ARUP Laboratories

Approva at Medicine Technology

Protalix BioTherapeutics, Inc. Receives Approval from the FDA to Initiate a Phase III Clinical Trial of prGCD

Phase III clinical trial may commence shortly CARMIEL, Israel, April 18, 2007 /PRNewswire-FirstCall/ ---Protalix BioTherapeutics, Inc. today announced that it has receivedwritten notice from the United States Food and Drug Administration(FDA) that it may initiate a Phase III clinical trial in the UnitedStates of its lead product candidate, prGCD, a proprietary plantcell expressed recombin...