FDA News

Data from the pivotal phase 3 FIGARO-DKD cardiovascular outcomes trial with finerenone reaffirms the agent's dual cardiorenal risk reduction benefits in T2D-associated CKD.

Abelacimab is a dual-acting, fully human monoclonal antibody that selectively targets both factor XI and factor XIa with high affinity.

The FDA EUA amendments for updated booster vaccinations are based on clinical studies of the omicron BA.1 variant and preclinical data on the BA.4 and BA.5 variants.

The dextromethorphan HBr-bupropion HCI combination uses the first new oral MOA in 6 decades and is labeled to improve depressive symptoms starting at 1 week.

Moderna filed with the FDA for emergency use authorization of a 50-µg dose of a BA.4./BA.5 Omicron-targeting bivalent booster vaccine for those aged ≥18 years.

Pfizer-BioNTech filed with the FDA for emergency use authorization of a 30-mcg dose of an Omicron BA.4.BA.5-adapted vaccine for those aged ≥12 years.

The FDA now recommends serial testing following a negative result on any at-home COVID-19 antigen test to reduce the risk of a false negative result.

A smaller dose given by intradermal injection will expand the total US supply by a factor of 5, FDA says.

Medicare Advantage plans may cut treatment corners to avoid more costly but more effective and targeted therapy for diabetes patients.

The FDA's move could potentially improve Paxlovid access for patients at high risk for severe COVID-19 who have limited access to health care.