Tag:
Avandia
Latest Headlines
Latest Headlines
Will FDA experts get last-minute Avandia documents?
You know what today is: FDA's expert advisors are meeting to determine the fate of GlaxoSmithKline's diabetes remedy Avandia . The agency delivered 700 pages of documents for the committee's perusal
Live from FDA: Nissen speaks on Avandia
GAITHERSBURG, MD -- Today is the day--the long awaited joint meeting of the FDA's Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees to discuss the
GSK withheld Avandia data, contends ex-FDA staffer
As the FDA's expert advisors prepare to hear arguments over the safety of GlaxoSmithKline's ( NYSE: GSK ) diabetes drug Avandia, one former agency staffer is preparing to testify in a liability suit
IOM report could weigh on Avandia trial
Should drugmakers really conduct clinical trials when potential safety problems arise with a marketed drug? That's the question FDA Commissioner Margaret Hamburg asked the experts at the Institute of
Avandia in the hot seat in EU, US
As the FDA preps for next week's advisory panel review of Avandia , European regulators have launched their own safety probe of the drug. Prompted by new studies released in June linking the
Cleveland Clinic finds high Avandia cardio risk
Researchers have turned to a second meta-analysis of existing clinical trials to address the question of cardiac safety in users of the GlaxoSmithKline diabetes drug Avandia. Their finding: "an
Avandia decision a bellwether for Obama FDA
Obviously, the fate of GlaxoSmithKline's ( NYSE: GSK ) diabetes drug Avandia is vital to the company. But it also will mark a defining moment for the Obama administration's FDA, as well as the entire
New studies find heart risks for Avandia
Imagine Avandia safety as an old-fashioned balance scale. Data on one side upholding the contention that the benefits of the GlaxoSmithKline ( NYSE: GSK ) diabetes med are worth its risks. Data on the
German watchdog nixes Avandia, Actos
German drug watchdogs aren't waiting around for the U.S. FDA to air Avandia concerns at next month's advisory panel meeting. The Federal Joint Committee simply told health insurers to stop paying for
Is FDA putting new Avandia risk data under wraps?
GlaxoSmithKline's ( NYSE: GSK ) diabetes drug Avandia has received a lot of bad press recently. The latest: The FDA may be delaying publication of a new Avandia study underscoring significant risks
