Drugs

FDA Approves Mallinckrodt Kidney Drug

FDA has approved Mallinckrodt’s Terlivaz (terlipressin) injection for improving kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function. The agency says Terlivaz is the first approved medication for this condition. HRS is most common in those with advanced cirrhosis and ascites, fluid buildup in the abdomen that is often related to liver disease, it says.

Approval was based on data from a double-blind study. “Twenty-nine percent of participants in the Terlivaz group had kidney function improvement compared to 16% of participants in the placebo group,” FDA says.

Because Terlivaz increases the risk of serious or fatal respiratory failure, FDA warns that patients with low oxygen in their blood should not start the medication. During treatment, patients should be monitored with a pulse oximeter, it adds.

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