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03.19.10
FDA Drafts New Rules For Testing, Approving Drug Cocktails; Public-Private Partnership For TB Treatment Development Launched

The FDA is drafting new guidelines for testing and approving multidrug cocktails for life-threatening diseases, the Wall Street Journal reports. "Many diseases, such as AIDS, tuberculosis and cancer, require multidrug combinations...

03.16.10
Advancing Interventional Radiology Treatment To Clear Blocked Carotid Arteries, Prevent Stroke

An important interventional radiology advancement - the use of a new cerebral protection device in combination with FDA-approved carotid stents in high-surgical-risk patients - provides a minimally invasive, safe and effective way to prevent stroke from occurring during treatment to clear blocked carotid arteries, according to research released at the Society of Interventional ...

02.11.10
First FDA-approved umbilical cord blood stem cells infusion trial in children with cerebral palsy

Medical College of Georgia researchers are conducting the first FDA-approved clinical trial to determine whether an infusion of stem cells from umbilical cord blood can improve the quality of life for children with cerebral palsy.

02.10.10
Repros Submits Response To FDA Regarding Androxal(R) Indication For Treatment Of Hypogonadal Men Wishing To Preserve Fertility

Repros Therapeutics Inc. (NasdaqCM:RPRX) announced that the Company, as requested by the FDA during the Type C meeting held on January 25, 2010, has sent a revised indication statement to the FDA's Division of Reproductive and Urologic Products for the use of Androxal® in the treatment of men wishing to preserve fertility while being treated for their hypogonadal state...

01.03.10
Health risks of wooden pallet shipping platforms, call for Congress and FDA regulation

The expanded recall of TYLENOL Arthritis pain reliever is fresh evidence of the need for Congress and the FDA to regulate wood pallets used to transport food and pharmaceuticals in the United States because of the dangers they pose to human health.

12.30.09
CPF reports success in advocacy, research support and awareness of PF

The Coalition for Pulmonary Fibrosis (CPF) calls 2009 a year of success in advocacy, research support and awareness, even in a year plagued by the economic recession. PF is a fatal disease that has no known cause, no FDA-approved treatment, and no cure.

12.07.09
Computer search algorithms identify FDA-approved drugs that could be the basis for new medicines

A massive, data-crunching computer search program that matches fragments of potential drug molecules to the known shapes of viral surface proteins has identified several FDA-approved drugs that could be the basis for new medicines -- if emerging viruses such as the H5N1(avian flu) or H1N1/09 (swine flu) develop resistance to current antiviral therapies -- according to a presentation at the American Society for Cell Biology (ASCB) 49th Annual Meeting, Dec. 5-9, 2009 in San Diego.

06.26.09
Vetericyn Inc. Launches Equine Wound & Infection Product Utilizing FDA-Cleared Technology

Vetericyn Inc., a California-based animal healthcare company, has announced the launch of its new Vetericyn™ equine product, available in a 16-ounce trigger spray for horses. Vetericyn™ utilizes an FDA-cleared technology that has been used to successfully treat over one million human patients without a single serious adverse effect. Now, the innovative topical wound-care product is available to the animal healthcare market.

06.25.09
Caldera Medical Announces FDA Clearance Of Novel Treatment For Pelvic Organ Prolapse

Caldera Medical, Inc. announced that it has received FDA clearance and CE Mark certification for the Ascend Pelvic Floor Repair System with Apical Support, a novel treatment for female pelvic organ prolapse. Ascend® is the latest addition to the Caldera Medical family of products designed to treat female stress urinary incontinence (SUI) and pelvic organ prolapse (POP).

06.14.09
PharmaCom BioVet, Inc. Begins To Review The Process To Potentially Receive Minor Use/Minor Species Drug Approval From FDA

PharmaCom BioVet, Inc. (PINKSHEETS: PHMB) is pleased to announce that the Company has begun the process to potentially apply and endeavor to receive a Minor Use/Minor Species (MUMS) drug approval from the Federal Drug Administration (FDA). Meeting the MUMS requirement is part of the New Drug Approval Process if the Company decides to potentially run clinical trials on a histone deacetylase inhibitor for canines with hemangiosarcoma, which the Corporation is considering the development of.

06.12.09
PharmaCom BioVet To File With FDA In Order To Perform Clinical Trials - Cancer Treatment For Canines

PharmaCom BioVet, Inc. (PINKSHEETS: PHMB) is pleased to announce that it is preparing a Form 21 CFR 511.1(b) for submission to the Federal Drug Administration (FDA). This initial form is one of several required if the Corporation decides to potentially run clinical trials on a histone deacetylase inhibitor for canines, which the Corporation is planning to develop.

04.13.09
FDA To Review Safety, Effectiveness Of Some Older Medical Devices

FDA on Wednesday announced it will ask several medical device manufacturers to submit data detailing the safety and effectiveness of some of their products already available on the market, the New York Times reports. The manufacturers will have 120 days to submit the data (Harris, New York Times, 4/9).

04.05.09
ATS Supports FDA Tobacco Legislation: Crucial Bill Reaches Floor Of House

More than a decade after being first proposed, and millions of tobacco-related deaths later, FDA regulation of tobacco is close to becoming a reality. Bi-partisan legislation co-sponsored by Representatives Henry Waxman and Todd Platts is currently on the floor of the House that, if passed, would give the FDA the authority to oversee and regulate tobacco marketing and sales in the U.S. Nationally, there are more than 400,000 tobacco-related deaths annually in the U.S.

04.03.09
U.S. House Takes Giant Step Toward Historic Regulation Of Tobacco Products

The following is a statement of Matthew L. Myers, President, Campaign for Tobacco-Free Kids: The U.S. House of Representatives today put Congress on the brink of truly historic action to reduce tobacco use -- the nation's No. 1 cause of preventable death -- by approving legislation granting the FDA authority over tobacco products. We urge the Senate to quickly pass this legislation and resist all efforts to weaken it.