FDA News

The NDA for daprodustat, a novel investigational agent, is based on data from pivotal ASCEND program clinical trials.

The FDA recently announced it had issued an emergency use authorization for the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with SARS-CoV-2 infection.

Another new COVID-19 vaccine, the first and only once-daily amphetamine transdermal patch approved for the treatment of ADHD, and 5 more.

Dupilumab is the only biologic to show positive, clinically meaningful phase 3 results in adults and adolescents 12 years and older with EoE.

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.