FDA News

The Pfizer-BioNTech COVID-19 vaccine is the first to receive full approval from the FDA.

The novel prandial insulin formulation from Eli Lilly is now approved for administration via continuous subcutaneous insulin infusion with an insulin pump.

The new indication for empagliflozin is to reduce risk of CV death and hospitalization for heart failure in patients with HFrEF,

In a new joint statement, the HHS officially recommends booster shots of mRNA COVID-19 vaccines and outlines plan to start rollout this fall.

Update: The FDA authorized a 3rd COVID-19 vaccine dose for the immunocompromised to combat emergence of more pathogenic SARS-CoV-2 strains.

The approval represents the first new treatment for generalized systemic lupus erythematosus in over a decade.

FDA approval of mezopelumab follows the phase 3 SYNAPSE trial in which the anti-Il-5 monoclonal antibody reduced by 57% the need for nasal polyp surgery.

The first nonsteroidal mineralocorticoid receptor antagonist to be approved for adults with T2D-associated CKD fills a significant treatment void for millions of patients.

From obesity to pneumococcal disease, we have picked the top 6 FDA-approved drugs every primary care physician should know about from the second quarter.

Tezepelumab, a novel human monoclonal antibody that shows promise to reduce exacerbations across asthma phenotypes, was granted FDA Priority Review.