drug safety

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

Equal time for risk info in ads, FDA says

Increasingly, the FDA wants drugmakers to give equal billing to the possible risks of taking drugs, not just rattle them off in the last few seconds of a TV commercial or bury them deep in print.

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

Merck to fight $8M Fosamax verdict

Merck (NYSE: MRK) has lost its first Fosamax jury trial. A New York jury awarded $8 million in damages to plaintiff Shirley Boles, who claimed her osteonecrosis of the jaw was caused by the

Did the FDA drop the ball on Mylotarg?

Pfizer's (NYSE: PFE) withdrawal of Mylotarg from the U.S. market is raising questions about the FDA and its accelerated-approvals program. The questions come in light of clinical research showing

Pfizer faces trials in hundreds of Prempro suits

Will Pfizer (NYSE: PFE) now have some impetus to settle the thousands of Prempro lawsuits it acquired along with Wyeth last year? Maybe, with hundreds of the suits moving from the pretrial stage

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