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The FDA plans to expand its capabilities in high performance computing to help build disease models and simulate clinical trials — as well as establish a new framework for regenerative medicine this fall — as part of an agency “innovation initiative” announced Friday by Commissioner Scott Gottlieb. Read More
Drugs labeled as sterile were exposed to unsanitary conditions and may have been contaminated with filth and may be harmful if given to patients. Read More
A federal judge has barred an Alabama compounder from manufacturing, holding or distributing drugs until the facility complies with FDA regulations. Read More
The update to EMA’s 2007 guidance would discuss how to assess results aimed at showing a vaccine is as good as or better than a product already on the market. Read More
A new class-action lawsuit from a terminal blood cancer patient claims that Celgene abused consumer safety regulations to monopolize cancer drugs. Read More
A federal jury awarded GlaxoSmithKline $235 million in a suit against Teva, saying the generics manufacturer infringed on GSK’s patent for the cardiovascular drug Coreg when Teva marketed its generic for chronic heart failure as well as high blood pressure. Read More