Biologics

FDA OKs Chikungunya Vaccine

FDA has approved a Valneva Austria BLA for Ixchiq, a vaccine for preventing chikungunya in individuals aged 18 years and above who are at heightened risk of exposure. Chikungunya, a mosquito-borne virus, has emerged as a global health threat, with over five million reported cases in the last 15 years, according to an FDA news release.

“The highest risk of infection is in tropical and subtropical regions of Africa, Southeast Asia, and parts of the Americas where chikungunya virus-carrying mosquitos are endemic,” the agency says. “However, chikungunya virus has spread to new geographical areas causing a rise in global prevalence of the disease.” Commonly characterized by symptoms such as fever, joint pain, rash, headache, and muscle pain, chikungunya can lead to severe and prolonged health issues, especially among older adults and those with underlying medical conditions.

The vaccine’s approval is based on data from two clinical studies in which about 3,500 participants received a dose of the vaccine or a placebo, the agency says. The most common side effects reported by vaccine recipients were headache, fatigue, muscle pain, joint pain, fever, nausea and tenderness at the injection site. FDA says it is also requiring the company to conduct a postmarketing study to assess the serious risk of severe chikungunya-like adverse reactions following vaccineadministration of Ixchiq.

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