Regulatory Affairs Syndicator

WOOD - WEDNESDAY, July 12 (HealthDay News) — The first once-a-day combination drug treatment for people with HIV/AIDS gained approval Wednesday from the U.S. Food and Drug Administration and will soon be available to patients. The drug, called Atripla …

AMDL, Inc. , developer and marketer of tests for the early detection of cancer and other serious diseases, today said that it has completed studies and compiled the data previously requested by the U.S. Food …

Jacksonville Business Journal - 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 …

Dayton Business Journal - … is now available in U.S. pharmacies, Teva Neuroscience announced Monday. Teva Pharmaceutical Industries Ltd. , the Israel-based parent of Kansas City-based Teva Neuroscience, received approval for Azilect from the U.S. Food and Drug Administration on …

Posted: July 31st, 2006 by Steve Trinward “The government revived efforts Monday to widen access to the morning-after pill, but only to women 18 and older, issuing a surprise announcement that it was …

In Washington Monday, a sudden and unexpected step towards approving the morning after pill for over the counter sales was taken.

New stop-smoking drug shows promise, but so did othersUSA Today - 1 hour ago… Acomplia, a drug available in Europe for weight loss, also has shown potential for helping smokers quit, but the Food and Drug Administration hasn't approved …

The Food and Drug Administration says it hopes to move forward on making emergency contraception available without a prescription. The agency made the announcement a day before a hearing on Capitol Hill on the nomination of Andrew von Eschenbach to be the FDA commissioner.

OLYMPIA — The Food and Drug Administration today advised against eating raw oysters harvested in Washington state, citing a recent rash of bacteria-caused illnesses that have sickened people on both coasts.

STAAR expands visual horizonsWhittier Daily News, CA - 2 hours ago… Bailey said his firm will also continue to seek approval from the State Food and Drug Administration of the People's Republic of China for its Visian Toric … Staar S…

San Francisco Business Journal - 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 …

Indy Channel - INDIANAPOLIS — Federal regulators warned pharmaceutical maker Eli Lilly and Co. on Monday about a “misleading” marketing brochure for its cancer drug Alimta. The Food and Drug Administration said Indianapolis-based company published a 34-page …

Xillix Technologies Corp. widened its second-quarter loss on lower sales and continued research and development expenses.

OLYMPIA - The Food and Drug Administration on Monday advised against eating raw oysters harvested in Washington state, citing a recent rash of bacteria-caused illnesses that have sickened people on both coasts.

Centre For Infectious Disease Research and Policy - Full payment to Cangene hinges on the product being approved by the US Food and Drug Administration (FDA); however, the contract permits delivery of the product before FDA approval in an emergency. The HHS had previously awarded Cangene and …