Drugs

FDA OKs Ofev for Lung Disease Scarring

FDA has approved Boehringer Ingelheim Pharmaceuticals’ Ofev (nintedanib) oral capsules to treat patients with chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype. “Chronic fibrosing ILD with a progressive phenotype encompasses a group of fibrotic lung diseases caused by different underlying diseases or conditions, including autoimmune ILD, hypersensitivity pneumonitis and idiopathic nonspecific interstitial pneumonia,” FDA says in a news release. (XXINSERT LINKXX) Characteristics of chronic fibrosing ILD include lung scarring and rapid disease progression, as assessed through worsening lung function tests, symptoms or imaging, it says. Progressive lung scarring leads to breathlessness and respiratory failure.

Ofev’s approval was based on data from a randomized, double-blind, placebo-controlled study involving 663 adults. After 52 weeks, people who received Ofev had less lung function decline compared to those on the placebo, the agency says. The most common side effects reported in the Ofev clinical trial were diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache and weight loss, 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