Biologics

Valneva Withdraws BLA for Chikungunya Vaccine

Valneva says it has voluntarily withdrawn its BLA for Ixchiq, the company’s chikungunya vaccine, based on FDA safety-related restrictions on the product. In 8/2025, CBER suspended Valneva’s BLA due to serious safety concerns that the vaccine could be causing chikungunya-like illness in vaccine recipients. The vaccine was granted accelerated approval in 2023 for preventing disease caused by the chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV.

In 5/2025, FDA issued a safety communication that recommended a pause in the vaccine’s use in individuals 60 years of age and older while an investigation of postmarketing reports of serious adverse events was undertaken, including neurologic and cardiac events, in individuals who have received the vaccine.

Valneva says FDA has now placed a clinical hold on the company’s IND for the vaccine pending an investigation into a newly reported foreign serious adverse event. According to the company, the adverse event occurred outside the U.S. and involved a younger adult who received three vaccines at the same time, including the chikungunya shot. Valneva said the case may be plausibly related to vaccination, but that causality has not been established. The company said it has reported the case to the U.S. Vaccine Adverse Event Reporting System and other pharmacovigilance systems and is seeking additional information to further assess the incident.

Valneva said there are currently no clinical studies actively vaccinating participants with the chikungunya vaccine and that it plans to proceed with post-marketing clinical activities, subject to discussions with regulators. The company added that it is continuing to review the vaccine’s global commercial prospects based on medical need and market attractiveness.

Chikungunya is a mosquito-borne viral disease that causes fever and severe joint pain that can persist for months or years. Since its resurgence in the mid-2000s, the virus has spread widely across Asia, Africa, Europe and the Americas, with millions of cases reported in the past decade.

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