FDA News

The first-of-its kind combination home-based test matched lab-based PCR tests for identification of influenza A and B and COVID-19.

Pfizer will present pivotal phase 3 data for RSVpreF to the ACIP on February 23; FDA has set a PDUFA date for the vaccine candidate of August 2023.

The novel oral agent is administered once daily for 14 days and has demonstrated rapid and sustained improvement in symptoms across trials.

The approval offers patients the choice to administer the monoclonal antibody at home using a prefilled device or to continue to receive it in a clinical setting.

The FDA and CDC must adopt the VRBPAC recommendation before it can be considered for implementation.

The FDA wants clinicians to avoid using the neutralizing antibody as it appears to be less effective against newer circulating strains of the SARS-CoV-2 virus.

Bexagliflozin significantly improved glycemic control in adults when used as monotherapy, in combination with metformin, or when added to several SOC regimens.

The update removes a previous limitation that stated semaglutide should not be used as an initial therapy for treating patients with T2D.

Get a quick look at 15 of the many FDA-approved drugs in 2022 for conditions commonly seen in primary care.

Lenacapavir is the first of a new class of antiretrovirals, and it is indicated for persons with multidrug resistance, intolerance, or safety considerations.