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FDA continues review of Takeda's NDA for Alogliptin

Takeda Pharmaceutical Company Limited has announced that Takeda Global Research and Development Center, Inc., a wholly owned United States (U.S.) subsidiary, received notification that the U.S. Food and Drug Administration (FDA) will not be able to complete its review of the alogliptin New Drug Application (NDA) by the Prescription Drug User Fee Act (PDUFA) date of October 27, 2008.

12 Oct 2008

FDA approves second-generation TAXUS Liberte Paclitaxel-Eluting Coronary Stent System

Boston Scientific Corporation has announced it has received approval from the U.S. Food and Drug Administration (FDA) to market its second-generation TAXUS Liberte Paclitaxel-Eluting Coronary Stent System.

12 Oct 2008

FDA licenses Kogenate FS to prevent joint damage in children with hemophilia A

The U.S. Food and Drug Administration has approved a new use for the blood product Kogenate FS to reduce the frequency of bleeding episodes and prevent joint damage in children with the most severe form of hemophilia.

12 Oct 2008

FDA approves Rapaflo for treatment of symptoms due to benign prostatic hyperplasia

The U.S. Food and Drug Administration today approved Rapaflo (silodosin) capsules for the treatment of symptoms due to benign prostatic hyperplasia (BPH), a condition also known as an enlarged prostate.

12 Oct 2008

FDA licenses for marketing Cinryze for hereditary angioedema

The U.S. Food and Drug Administration today licensed for marketing the first product in the United States intended to protect people with hereditary angioedema (HAE), a rare and potentially life-threatening genetic disease. HAE affects about 6,000 to 10,000 individuals in the United States.

12 Oct 2008

Little use of biological alternatives to chemical pesticides

The increasing demands from many consumers in this day and age for fruit and vegetables which have been grown free of chemical pesticides, has put scientists under pressure to find biological alternatives.

12 Oct 2008

Microwave ovens need more safety features to protect youngsters

Microwave ovens should be equipped with safety controls to prevent children from opening them and being burned by hot foods and drinks, according to a study published today by University of Chicago Medical Center researchers in the October 2008 issue of the journal Pediatrics.

6 Oct 2008

School vending machines dole out excess calories and added sugar beverages

Despite efforts to include more healthy choices at schools, standard offerings from vending machines - including fruit juices - are giving students more calories than they need.

6 Oct 2008

Helicobacter pylori may help prevent adenocarcinoma, esophageal cancers

Some bacteria may help protect against the development of a type of esophageal cancer, known as adenocarcinoma, according to a new review of the medical literature. These bacteria, which are called Helicobacter pylori, live in the stomachs of humans.

6 Oct 2008

FDA accepts ATryn biologics license application

The US Food and Drug Administration, or FDA, has accepted for review GTC Biotherapeutics, Inc.'s Biologics License Application, or BLA, for ATryn.

6 Oct 2008

How much do you need to exercise?

Researchers in the United States say people who are struggling with their weight often underestimate how many calories they are actually consuming, which hinders their weight loss efforts.

6 Oct 2008

Improper cooking linked to 32 cases of Salmonella in the U.S.

Following another outbreak in the United States of salmonella, Americans have been warned to follow the cooking instruction on the labels of some prepared chicken products.

6 Oct 2008

Too many Australian children have an unhealthy lifestyle

A survey on the lifestyle of Australian children has found big changes need to be made if many are to avoid health problems later on in life.

6 Oct 2008

FDA issues interim safety and risk assessment of Melamine and Melamine-related compounds in food

The U.S. Food and Drug Administration (FDA) has issued the results of its interim safety and risk assessment of melamine and melamine-related compounds in food, including infant formula.

5 Oct 2008

Exelixis files investigational new drug application for anticancer compound

Exelixis, Inc. announced today that it has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration for XL888, a novel anticancer compound. XL888 is an orally available small molecule inhibitor of HSP90, which is a chaperone protein that promotes the activity and stability of a range of key regulatory proteins, including kinases.

2 Oct 2008

Nanoparticles, so small, seep right through the skin

Scientists are warning that tiny particles - nanoparticles - are so small that they can be absorbed through the skin.

1 Oct 2008

Food nutrition labelling in the "too hard basket" for many shoppers

A series of almost weekly food scares from China and the U.S. have made many consumers more aware of what goes into a food product and concern over where the ingredients are sourced from, but experts suggest many shoppers 'ignore food label schemes'.

1 Oct 2008

Shoppers happier with 'traffic light' food labelling

A recent survey by a consumer advocacy group in Australia has found that a "traffic light" labelling system is more popular with the public than the current daily intake guide labelling system.

1 Oct 2008

New test for rapid detection of influenza

The Association of Public Health Laboratories (APHL) collaborated with the Centers for Disease Control and Prevention (CDC) in the development of a new test for influenza, which received 510(k) clearance today by the Food and Drug Administration (FDA).

30 Sep 2008

$2.5 billion to modernize U.S. health IT systems

The U.S. Food and Drug Administration today announced the selection of ten contractors to receive up to a total of $2.5 billion for information technology (IT) and data center management services over the next ten years.

30 Sep 2008