NEJM retracts pivotal data behind Amgen's Tavneos after FDA probe finds results for 9 patients re-evaluated post-unblinding; EU also moves to revoke.
Pivotal data for Amgen’s Tavneos have been retracted from the New England Journal of Medicine, creating another obstacle for the beleaguered autoimmune drug.
Two academic …
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NEJM Retracts Pivotal Trial of FDA-Approved Drug
FDA findings lead to medical journal paper retraction | The Jerusalem Post
Europe's CHMP reverses endorsement of Amgen's Tavneos as FDA hearing looms
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EMA's CHMP recommends revoking Tavneos' marketing authorization over flawed clinical data, as US approval also hangs in the…
Move follows actions 'inconsistent with proper research conduct,' journal says
An Amgen spokesperson said it "takes scientific integrity seriously and respects the role of journals in upholding the peer…
Amgen has taken steps to update its Tavneos label amid an ongoing battle with the FDA.
As Amgen prepares to defend Tavneos’ market approval in the U.S., the company has received a bad omen overseas, with regulators…
Amgen has asked the FDA to review evidence that its drug Tavneos (avacopan), which treats a rare form of vasculitis, is worth…
