FDA News

Howard Fillit, MD, cofounder/chief scientific officer of the Alzheimer Drug Discovery Foundation, says lecenumab's approval opens the door for future drug development.

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.