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FDA should amend the product information for irinotecan

Not everyone needs a genetic test before taking the cancer drug irinotecan, and the U.S. Food and Drug Administration should modify its prescription guidelines to say so, according to researchers at the University of North Carolina at Chapel Hill.

29 Aug 2007

Indevus submits new drug application for NEBIDO

Indevus Pharmaceuticals, Inc. has announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for NEBIDO (testosterone undecanoate) intramuscular injection, a long-acting testosterone therapy intended to treat male patients with primary and secondary hypogonadism.

29 Aug 2007

How does Listeria monocytogenes survive with nothing to live on?

Try going for a couple of weeks without food and see what shape you're in, or if you're around at all by then. Let some dangerous bacteria do the same thing and there's a chance they may do more than survive; they can grow stronger and remain as virulent as ever.

29 Aug 2007

FDA approves cobas TaqScreen WNV test for West Nile virus

The U.S. Food and Drug Administration has announced approval of a second test for the detection of West Nile virus (WNV) in blood and organs.

29 Aug 2007

FDA approves new Roche direct detection of West Nile Virus in donated human blood

Roche Diagnostics announced that the US Food & Drug Administration (FDA) has approved its biologics license application for the company's test for direct detection of West Nile Virus in donated human blood and plasma.

From Roche Sequencing and Life Science 29 Aug 2007

FDA grants orphan drug designation to TREANDA

Cephalon, Inc. announced today that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development granted orphan drug designation for the company's investigational therapy, TREANDA (bendamustine HCl), for the treatment of chronic lymphocytic leukemia (CLL).

29 Aug 2007

FDA approves Evithrom (human thrombin)

The U.S. Food and Drug Administration has approved Evithrom (human thrombin), a blood-clotting protein used to help control bleeding during surgery.

28 Aug 2007

IDM Pharma receives not approvable letter for Mifamurtide for treatment of osteosarcoma

IDM Pharma, Inc. ( NASDAQ:IDMI ) announced today that it received a not approvable letter from the U.S. Food and Drug Administration (FDA) after completing the review of the new drug application (NDA) for the investigational drug mifamurtide (L-MTP-PE), formerly known as Junovan, for the treatment of non-metastatic osteosarcoma, a rare and often fatal bone tumor that typically affects children and young adults.

28 Aug 2007

Cervical disc to treat degenerative disease gets FDA green light

The Food and Drug Administration (FDA) in the U.S. has given approval for a cervical disc implant to treat patients with degenerative disc disease.

28 Aug 2007

Imported Indian toothpaste a cause for concern again in Canada

The latest food scare to hit North America emanates this time over products imported from India rather than China.

28 Aug 2007

Mars pet food recall over Salmonella

Another pet product has been recalled over fears it may be contaminated.

27 Aug 2007

Link between diabetes and high-fructose corn syrup in soft drinks

Researchers have found new evidence that soft drinks sweetened with high-fructose corn syrup (HFCS) may contribute to the development of diabetes, particularly in children.

24 Aug 2007

Risperdal approved for psychiatric conditions in children and adolescents

The U.S. Food and Drug Administration has approved Risperdal (risperidone) for the treatment of schizophrenia in adolescents, ages 13 to 17, and for the short-term treatment of manic or mixed episodes of bipolar I disorder in children and adolescents ages 10 to 17.

24 Aug 2007