The FDA did a hard about-face today on GlaxoSmithKline's diabetes drug Avandia, deciding that the drug presents no more heart risk than the most commonly used Type 2 diabetes drugs and withdrawing the label warnings and other restrictions.
GlaxoSmithKline said it reached a deal with 8 state attorneys general to resolve lawsuits involving the controversial diabetes drug Avandia. Together with a separate settlement with the state of Louisiana, related to other GSK products, the amounts promised total $229 million
The prevalence of diabetes is growing globally, and with that the size of the diabetes drug market. But the market has gotten increasingly competitive and increasingly complex. All of the top 10 best-selling drugs in the diabetes category are blockbusters, according to EvaluatePharma. So who makes them? Check out the report >>
It took multiple tries and a vote tallied on paper to make sure everything was correct, but finally, we have a verdict. After two days of hearings, on Thursday an advisory panel recommended the FDA keep Avandia on the market and ease restrictions on its use.
GlaxoSmithKline has launched a probe of a research study involving its employees from a research lab in Shanghai, China.
Dr. Thomas Marciniak, medical team leader of FDA's Division of Cardiovascular and Renal Products, made some expensive promises Wednesday morning before a panel of outside experts tasked with advising the FDA on whether to lift current restrictions on GlaxoSmithKline's diabetes drug Avandia.
Ahead of this week's FDA advisory panel meeting, staff reviewers backed a readjudication of the controversial RECORD trial, which found that the GlaxoSmithKline diabetes drug Avandia does not increase cardiovascular death risks.
The new analysis of Avandia safety data has made its debut. Verdict: The GlaxoSmithKline diabetes drug does not increase cardiovascular risk. What's that, you say? Wasn't Avandia pulled from the market in Europe and restricted in the U.S. for those very risks?
The FDA yesterday responded to a Forbes op-ed from Steven Nissen, Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, published earlier that day. In it, Nissen railed the...
Publicly disgraced after cardiologist Steven Nissen and his colleagues unveiled data on its cardiovascular risks in 2007, Avandia was withdrawn in Europe and put under tight rein in the U.S. Now, the FDA is revisiting the issue, and Nissen himself has issues with that.