We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA warned Omnicare for inadequate quality control systems for the fifth time in 11 years, causing the company to recall its products and close its drug repackaging facility.
Despite being the first to win final FDA approval -- with 180 days of exclusivity -- to manufacture and market generic Focalin, Teva Pharmaceutical still has to prevail in court against Novartis and Celgene.
Merck announced good sales growth for the last quarter of 2006 but noted a major drop in earnings due to special charges and an increase in reserves for future legal costs.
The Bush administration is not providing sufficient funding or making the argument for the FDA's effort to improve drug development, known as the Critical Path Initiative, observers say.
Amgen's anemia drug Aranesp should not be used to treat fatigue or to reduce the need for red blood cell transfusions in cancer patients because it is ineffective and potentially dangerous for these uses, the company said.
Genentech warned healthcare providers in a letter that use of eye drug Lucentis may increase the risk of stroke, particularly in patients who have already experienced a stroke.
The Bush administration is cautioning critics of the FDA budget to consider the agency's long-term plans when assessing the fiscal 2008 budget proposal.
The FDA warned Daiichi Sankyo for promotional items it said were misleading because they obscured risk information for Evoxac, a drug that treats dry mouth in patients with Sjogren's syndrome.
HHS' Agency for Healthcare Research and Quality (AHRQ) found the most commonly prescribed antidepressants are similar in effectiveness, but have varying side effects, according to a new report.