Drugs

FDA Approves Actelion’s Uptravi for PAH

FDA has approved Actelion Pharmaceticals’ Uptravi (selexipag) tablets to treat adults with pulmonary arterial hypertension (PAH). An agency news release says the drug is an oral IP prostacyclin receptor agonist that acts by relaxing muscles in blood vessel walls to dilate the blood vessels and decrese the elevated pressure in the vessels supplying blood to the lungs.

Uptravi’s safety and effectiveness were established in a long-term clinical trial of 1,156 participants with PAH. It was shown to be effective in reducing hospitalization for PAH and reducing the risks of disease progression compared to placebo. Common side effects in those treated with Uptravi included headache, diarrhea, jaw pain, nausea, myalgia, vomiting, pain in an extremity, and flushing.

FDA also granted Uptravi orphan drug designation.

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