Drugs

Panel Shoots Down FibroGen’s Roxadustat

FDA’s Cardiovascular and Renal Drugs Advisory Committee 7/15 overwhelmingly voted against recommending approval for a FibroGen NDA for roxadustat, indicated for treating anemia due to chronic kidney disease in adult patients not on dialysis and on dialysis. Committee members agreed with an FDA briefing document citing risks of serious thromboembolic events, as well as other risks (see earlier story). The committee voted 13-1 against the approval for treatment of chronic kidney disease in patients not on dialysis and 12-2 against the approval for patients on dialysis.

Roxadustat is an oral small molecule hypoxia-inducible factor prolyl hydroxylase inhibitor, according to the company. It is approved in China, Japan, Chile, and South Korea, and has received a positive opinion from the European Medicines Agency's Medicinal Products for Human Use Committee.

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