Regulatory Affairs Syndicator

Humira , one of the TNF inhibitors , has been approved by the U.S. Food and Drug Administration to treat the signs and symptoms of ankylosing spondylitis .

WISH-TV - INDIANAPOLIS The Food and Drug Administration is warning Eli Lilly and Company about a marketing brochure for a cancer drug. The F-D-A says the Indianapolis-based company published a 34-page patient brochure that is misleading because it doesn’t …

A study that spurred concern about high concentrations of platinum in women with silicone breast implants seems to contain flaws and should be viewed ‘with caution,’ the scientific journal that published the …

FDA warns Lilly for Alimta marketingFort Wayne News Sentinel, IN - 59 minutes agoThe Food and Drug Administration said Indianapolis-based company published a 34-page patent brochure that "omits material facts and risk information essenti…

WNYT - _July 1999: Plan B is approved by the Food and Drug Administration for prescription use as an emergency contraceptive. _April 2003: Women’s Capital Corp. files an application with the FDA to make Plan B available without a prescription. _October 2003 …

BioLabs completes trialCrain’s Cleveland Business, OH - 3 hours ago… results of clinical trials of a radioprotective drug on monkeys — something it said it hopes will help to secure US Food and Drug Administration approval of …

The US Food and Drug Administration said Monday it was resuming its review of whether the “morning after” anti-contraception pill can be sold without a doctor’s prescription.

WASHINGTON - Consumers should avoid eating raw oysters harvested from the Pacific Northwest, U.S. health officials warned on Monday after reports of stomach illnesses linked to bacterial contamination.The U.S. …

Barrier Therapeutics’ treatment for seborrheic dermatitis has been approved by the U.S. Food and Drug Administration, the company said in a statement.

Medimmune Seeks Expanded Flu Vaccine UseHouston Chronicle, United States - 4 hours ago— Drug maker Medimmune Inc. said Monday it asked the Food and Drug Administration to expand approval of its FluMist medication for children. … MedImmun…

Drug maker Medimmune Inc. said Monday it asked the Food and Drug Administration to expand approval of its FluMist medication for children.

East Bay Business Times - CBST) on the drug HepeX-B, but said Cubist stopped its investment in the project because of stringent Food and Drug Administration requirements. Xoma and Cubist made a deal in September 2005 in which Xoma worked to find new ways of manufacturing …

The Food and Drug Administration is advising consumers to avoid eating raw oysters harvested in the Pacific Northwest as a result of reports that some of the oysters recently harvested from that region were contaminated with Vibrio parahaemolyticus (Vp), a bacteria that can cause gastrointestinal illness.

The Food and Drug Administration is advising consumers to avoid eating raw oysters harvested in the Pacific Northwest as a result of reports that some of the oysters recently harvested from that region were contaminated with Vibrio parahaemolyticus (Vp), a bacteria that can cause gastrointestinal illness.