Food and Drug Administration

...the potential opioid pain drug Exalgo. The agency said it is delaying a decision on the treatment by three months, to Feb. 22. The FDA was scheduled to make a decision by Nov. 22, but the company sent in additional information on the drug...

In this article: NEW YORK and Ireland

SEATTLE (AP) - Biotechnology company Dendreon Corp. said Friday the Food and Drug Administration will make a regulatory decision on the potential prostate cancer vaccine Provenge by May 1. The drug is aimed at treating prostate cancer. It...

In this article: Cancer

* Dendreon says FDA has accepted Provenge application * Says will respond to the application by May 1, 2010 Dendreon Corp <DNDN.O> said on Friday that the U.S. Food and Drug Administration has accepted its application to market its...

In this article: U.S. Food and Drug Administration, Cancer, Los Angeles, Atlanta, and New Jersey

...service providers to shut off nearly 12 dozen Web sites alleged to be selling counterfeit or unapproved prescription drugs. The FDA's office of criminal investigations said it sent 22 warning letters to the operators of the sites, and...

In this article: FDA, United States, Order fulfillment, E mail, Levitra, Viagra, Acomplia, and Anxiety

(Adds details) Actelion Ltd <ATLN.VX>, Europe's largest biotech company, said on Thursday the U.S. Food and Drug Administration (FDA) would review use of its drug Zavesca to treat a rare neurodegenerative disease early next year. The...

In this article: FDA, United States, Niemann-Pick, Neurodegenerative disease, Gaucher disease, and Endocrine

...panel of vaccine experts voted 10-1 in favor of Pfizer's Prevnar 13 to protect against pneumococcal disease. While the FDA is not required to follow the group's advice, its recommendation moves the company closer to expanding the...

In this article: Pfizer, Wyeth, GlaxoSmithKline, Merck, Meningitis, European Union, and U.S.

...letter," which is typically a request for some type of information or input. The companies did say the FDA is not asking for new data on the drug and that it is still in discussion over the drug's labeling. Genentech would not comment...

In this article: Genentech, Biogen, Rituxan, Leukemia, Cancer, Rheumatoid arthritis, Cambridge, and NEW YORK

...for preventing and identifying problems with its devices, documenting those problems, and the speed with which it informs the FDA of any issues. The agency also cited problems with Medtronic's quality control for suppliers. Medtronic...

In this article: Medtronic, Minneapolis, Mounds View, Minn., NEW YORK, and Minnesota

...had with its leads that are used with implantable cardioverter defibrillators, known as ICDs. The FDA issued the warning letter after it completed its inspection of the facility in August. The company will respond to the letter within 15...

In this article: Medtronic, Mounds View, Minnesota, New York Stock Exchange, and U.S.