Drugs

FDA OK’s Expanded Use for Vertex’s Symdeko

FDA has expanded the indication of Vertex Pharmaceuticals’ Symdeko (tezacaftor/ivacaftor) tablets for treating pediatric patients aged six years and older with cystic fibrosis who have certain genetic mutations. Last year, Symdeko was approved to treat patients ages 12 and older who had the same specific genetic mutations.

Cystic fibrosis is caused by a defective protein that results from mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, an agency release says. There are about 2,000 known mutations of the CFTR gene, and Symdeko is used to treat patients who have two copies of the most common type of mutation – F508del mutation – or who have at least one of the mutations in the CFTR gene that is responsive to the active ingredients in Symdeko based on in vitro data or clinical evidence. “Patients with cystic fibrosis and their caregivers should speak with a health care professional and have tests performed to understand which gene mutations patients have and whether Symdeko is likely to work for them,” FDA says.

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