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The FDA approved Gazyva for the treatment of patients with follicular lymphoma who relapsed after, or are resistant to, a rituximab-containing regimen. Read More
The FDA cited multiple problems with labeling claims at a Phoenix manufacturer that specializes in colostrum, the milk produced by maternal mammals immediately after giving birth. Read More
The European Medicines Agency conducted 15 percent more inspections for compliance with good clinical practices in 2016 than in 2015, the agency reported. Read More
Baxter International will divest the rights to two drugs held by Claris Lifesciences to offset the anticompetitive effects of its acquisition of Claris, under terms of a final FTC order. Read More
The European Medicines Agency has begun to adopt a new addendum to the ICH’s 1998 clinical trial statistics guideline, as well as a revision to the 23-year-old ICH guideline on measuring drug risks to human reproduction. Read More
A mutual fund, citing $80 billion in losses on its investment in drugmaker Valeant, filed a lawsuit alleging securities violations, mail and wire fraud, and violations of the Racketeer Influenced and Corrupt Organizations Act (RICO). Read More