FDA News

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.

The FDA recommended on Thursday the inclusion of a SARS-CoV-2 Omicron component in COVID-19 vaccine booster doses.

If the atogepant label is expanded, the drug will be the only gepant approved for the broad indication of prevention of both episodic and chronic migraine.

The new approval for risankizumab makes it the only interleukin-23 inhibitor for moderately to severely active Crohn disease, according to AbbVie.

The FDA ban yesterday on Juul vaping devices and nicotine e-liquid pods drew praise from the American Medical Association, American Thoracic Society, American Lung Association, among others.