FDA News

Zavegepant, the first FDA-approved intranasal CGRP receptor antagonist, could be available in pharmacies by July 2023.

The SGLT-2 inhibitor, if approved for this age group, would be the first agent in the class with the indication as adjunctive treatment for T2D for those younger than age 18.

The prescription remote electrical neuromodulation device is now cleared for both acute and preventive treatment of migraine in those aged ≥12 years, according to Theranica.

The VRBPAC vote that the GSK data support the vaccine's efficacy was unanimous and on safety the vote was 10-2. PDUFA date set for May, 2023.

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.