FDA News

The US FDA approved norgestrel as the first daily oral contraceptive to be available over the counter, without a prescription.

The expanded indication widens the patient population eligible for the novel siRNA therapy to include high-risk patients on maximum statin Rx who have not had a CV event.

FDA's action, based on confirmatory evidence showing slowed disease progression, follows a January 2023 accelerated approval.

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.