FDA News

The novel Bigfoot Unity Diabetes Management System could help improve insulin dosing in patients with type 1 or type 2 diabetes.

The vaccine is indicated for prevention of invasive disease and pneumonia caused by 20 Streptococcus pneumoniae serotypes.

The FDA approved today the first drug that targets the pathophysiolgic process responsible for Alzheimer disease and the first drug since 2003 to be approved for any Alzheimer treatment.

More US teens prefer menthol-flavored e-cigarettes, significant surge in use of disposable e-cigarettes, and additional findings from the 2020 National Youth Tobacco Survey, here.

Agency expansion of the COVID-19 vaccine EUA to include this younger group is an important step toward achieving herd immunity in the US, particularly as vaccine uptake slows across the country.

Dapagliflozin is the first SGLT-2 inhibitor to receive FDA approval for the treatment of CKD, regardless of diabetes status.