Word is that US and European regulators will make separate announcements shortly about the future of Avandia . The status of GlaxoSmithKlin...

We're not ones to call advisory committee members names. We'll let them do that to themselves. "I was one of the brain-dead kan...

FDA Deputy Commissioner Joshua Sharfstein was asked repeatedly during a briefing with media: Who will make the final decision on Avandia ? H...

Today, FDA released an army of briefing documents ahead of the advisory committee re-review of GlaxoSmithKline's diabetes drug Avandia (...

Score one for FDA. As " Avandia Week" approaches, FDA made a decision to wrestle control of the debate over the safety and efficac...

The most important single event for FDA’s drug review in 2010 and possibly beyond is coming this summer: the advisory committee re-review of...

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The people have spoken, and they expect a long year ahead for GlaxoSmithKline. That’s because Avandia was the run-away winner in our poll b...

We here at the IN VIVO Blog do love our advisory committee meetings. The anticipation. The preparation. The smell of the reams of briefing...

When Steve Nissen is not qualified to serve on an FDA advisory committee under the agency’s new conflict of interest guidelines , you know t...

Avandia . Vioxx . Ketek . Elidel . Palladone . What do those drugs have in common? The obvious answer is that they are all associated with a...

Type 2 diabetes just entered the new era of drug development. FDA’s Endocrine & Metabolic Drugs Advisory Committee’s recommended (by a 1...

You don't have to have finely honed news instincts to realize that if GlaxoSmithKline failed to disclose everything it knew about Avandi...

If you’re an executive for a company with an FDA-regulated product, the agency’s inaugural Risk Communication Advisory Committee meeting had...

The buzz among investors is that a new Food & Drug Administration draft guidance on diabetes drug development makes an already tough reg...

The Avandia disaster is probably not what JP Garnier imagined he would spend most of his time talking about in his swan song as CEO of Glax...

“This is here to stay.” “This” refers to what outgoing GlaxoSmithKline CEO JP Garnier sees as a vicious cycle of safety signals damaging blo...

Blaming the media will never go out of fashion, at least not when it comes to drug safety scares. Here is Schering-Plough EVP Carrie Cox, su...

Nature reports today that a peer reviewer for the New England Journal of Medicine leaked to GlaxoSmithKline that big old Avandia meta-ana...

It’s the headline lay media outlets love to report: “High-Cost Cholesterol Drug Combo Shows No Benefit Over Lower-Cost Generic Statin.” From...