Drugs

FDA Complete Response Letter for Ardelyx’ Tenapanor NDA

FDA has sent a complete response letter to Ardelyx for its NDA for tenapanor for the control of serum phosphorous in adult patients with chronic kidney disease on dialysis. The company says FDA found that the submitted data provide substantial evidence that tenapanor is effective in reducing serum phosphorous in the target patients but the magnitude of the treatment effect is small and of unclear clinical significance.

FDA also reportedly said that for the NDA to be approved, Ardelyx would have to conduct an additional adequate and well-controlled trial demonstrating a clinically relevant treatment effect on serum phosphorous or an effect on the clinical outcome thought to be caused by hyperphosphatemia in chronic kidney disease patients on dialysis.

The company says it will seek a meeting with FDA to discuss options for obtaining approval.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome