Electromed, Inc. (NYSE MKT: ELMD), a global medical device company, today announced it has received notification from the U.S. Food and Drug Administration that its next generation SmartVest® Airway Clearance System, the model ...
Impact Sports Technologies, Inc., the industry leader in innovative motion resistant strapless heart rate applications, has received its 18th patent, featuring the use of its mobile optical heart rate monitoring technology with a mobile ...
Tags: Impact Sports Technologies, patent
Netherlands-based Micreos has received generally recognized as safe (GRAS) food processing aid against Salmonella status for its SALMONELEX from the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA). ...
Tags: Micreos, Salmonelex
Genzyme, a Sanofi company (EURONEXT:SAN and NYSE:SNY), announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental Biologics License Application seeking approval of ...
Tags: Genzyme, Biologics License Application, Lemtrada, multiple sclerosis
Veloxis Pharmaceuticals A/S (OMX: VELO), today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of Envarsus® (formerly ...
Tags: Veloxis Pharmaceuticals, New Drug Application, Envarsus®
In a study published November 20, 2013 in the New England Journal of Medicine, researchers looked at the association of nut consumption with total and cause-specific mortality among 76,464 women in the Nurses' Health Study and 42,498 men in ...
Ikaria, Inc., a critical care company focused on developing and commercializing innovative therapies designed to address the significant needs of critically ill patients, announced today that its investor group and employee shareholders ...
Tags: Ikaria, sell the Commercial Business, Madison Dearborn Partners
Actavis plc (NYSE: ACT) today confirmed that its subsidiary, Warner Chilcott Company LLC, has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Ethinyl Estradiol and ...
Tags: Actavis, Warner Chilcott Company LLC, Abbreviated New Drug Application
The U.S. Food and Drug Administration (FDA) was busy in 2013, especially when it came to the Food Safety Modernization Act (FSMA). As the year draws to a close,?Food Safety News decided to take a look back at the agency's comings and ...
Tags: Agriculture, Food
Denmark-based pharmaceutical company ALK-Abello has announced that the FDA Allergenic Products Advisory Committee of the US Food and Drug Administration (FDA) will meet on 28 January 2014 to discuss the biologic license application (BLA) ...
The French maker of a drug used to treat multiple sclerosis is "extremely disappointed" it was rejected for U.S. sale, a corporate official said. David Meeker, president of Sanofi's Genzyme subsidiary, maker of the drug Lemtrada, said he ...
Today confirmed that its subsidiary, Warner Chilcott Company LLC, has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Ethinyl Estradiol and Etonogestrel Vaginal ...
Xiaflex (collagenase clostridium histolyticum) has been approved by the U.S. Food and Drug Administration to treat Peyronie's disease, an uncomfortable curvature of the penis. The drug -- first sanctioned three years ago to treat a hand ...
Tags: Xiaflex, collagenase clostridium histolyticum, Peyronie's disease
The first drug treatment for unusual curvature of the penis has been approved by the U.S. Food and Drug Administration, the agency announced Friday. Men with the condition, called Peyronie's disease, have a lump in the penis that causes ...
Tags: curvature of the penis, Peyronie's disease, FDA, men health
Does it really cost more to stick to a healthy diet? The answer is yes, but not as much as many people think, according to a new study. The research review combined the results of 27 studies from 10 different countries that compared the ...
Tags: healthy diet, cost of healthy diets, cost of unhealthy diets