FDA News

Tirzepatide, a novel once-weekly GLP-1/GIP mimetic that binds to receptors and stimulates glucose-dependent insulin release, has shown superiority over many common antihyperglycemics.

Administration of the J&J vaccine is now limited to those aged ≥18 years who cannot access other COVID-19 vaccines or are unable to receive them.

The cardiac myosin inhibitor is the only treatment that targets the pathophysiology of the disease, improving patient function and symptoms.

The US FDA expanded approval of remdesivir this week to include pediatric patients aged 28 days and older, the first COVID-19 treatment indicated for this population.

The biotechnology company said on Thursday that similar requests are underway with international regulatory authorities.

A nondescript, postage-paid envelope accompanying an opioid prescription, and patient education on discarding unused tablets are proposed.

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.