FDA News

The higher dose of the GLP-1 analogue allows more flexibility for patients with T2D needing to intensify treatment, says manufacturer Novo Nordisk.

The FDA authorized a second booster dose of the Pfizer or Moderna COVID-19 vaccines for people aged over 50 years and certain immunocompromised persons.

Persons with HIV now have the option to forego initiation of the long-acting injectable with oral formulations of the medications, according to a statement from Viiv Healthcare.

Injuries have included accidental use of test solution as eyedrops and children ingesting test parts and swallowing test solution.

The FDA has approved the first generic budesonide and formoterol fumarate dihydrate inhalation aerosol for the treatment of asthma and COPD.

The landmark approval for the SGLT-2 inhibitor will open access to treatment for the ~ 3 million adults with heart failure with preserved ejection fraction.

t:slim X2 insulin pump users can now program or cancel bolus dosing with the secure t:connect mobile app already on their phones, says Tandem Diabetes Care.

The 180-day sensor life doubles the period of continuous use and cuts in half the number of CGM removals and reinsertions, without loss of accuracy.

Acting FDA Commissioner Janet Woodcock, MD, hopes the approval will help motivate more Americans to get vaccinated.

The end of another quarter means a new list of FDA-approved drugs for conditions treated in primary care. Are you up-to-date? Click through to find out.