Drugs

Valneva Chikungunya OK to Use Again: FDA

FDA has lifted its recommended pause on the use of Valneva’s Ixchiq for chikungunya virus. The agency also has approved updates to the vaccine’s Prescribing Information (PI) to reflect new safety data, particularly in older individuals with chronic health conditions. Ixchiq remains approved in the U.S. for use in adults 18 years and older who are at high risk of exposure to chikungunya virus, a mosquito-borne disease that causes fever, rash, fatigue and often-debilitating joint and muscle pain.

The agency has emphasized that for most U.S. travelers, the risk of chikungunya exposure remains low, and use of the vaccine is not recommended for the general population. Instead, Ixchiq should be reserved for those facing significant exposure risks, and healthcare providers are advised to weigh the benefits and risks carefully before vaccination, the company says. The updated label also reiterates that the product is contraindicated in immunocompromised individuals, including those with diseases or treatments that suppress immune function.

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