FDA News

KidneyIntelX.dkd, a first-in-class AI-enabled prognostic test, stratifies risk of DKD progression in 5 years and is specific for early stage disease.

The 2 new vaccines are authorized for adults aged 60 years and older and with CDC Director Walensky's final nod, should be available this fall.

The 2 SGLT-2 inhibitor-based medications are the first in the class to be approved for pediatric T2D and provide a much needed additional oral treatment option for the population.

Colchicine 0.5 mg is associated with reduction in a wide range of CV events in patients already on statin therapy, supporting the long-held "anti-inflammatory" hypothesis.

The FDA's VRBPAC members were unanimous in their recommendation that the 2023-24 COVID vaccines reflect the dominant strain in circulation, XBB.

The FDA advisory committee will review all current surveillance data and recommend which strain/s to include in updated COVID-19 vaccines for the 2023-2024 vaccination campaign.

Nirsevimab, a long-acting monoclonal antibody, if approved, will be indicated to prevent RSV LRTD in neonates and infants born during or entering into their first RSV season.

Proposed indications for the investigational factor XIa inhibitor are: stroke prevention after acute ischemic stroke or high-risk transient ischemic attack; recent acute coronary syndrome; and atrial fibrillation.

Compounded versions of semaglutide, often sold online, may contain salt versions of the molecule and are not evaluated by the FDA for safety or efficacy.

The FDA's decision was based on data from the pivotal phase 3 RENOIR trial, which demonstrated the efficacy, immunogenicity, and safety of Abrysvo in adults aged ≥60 years.