FDA News

Early phase 2a study results of a combination of the 2 agents previously evaluated as NASH monotherapies led to the FDA award for Pfizer.

The Labcorp home test, available without a prescription, is delivered overnight and includes a return envelope. Results are available in 1-2 days.

Dupilumab is approved for the treatment of eosinophilic esophagitis in patients aged ≥12 years weighing at least 40 kgs.

Children aged 5 to 11 years can receive a single dose booster shot 5 months after completing a primary 2-dose series of the Pfizer COVID-19 vaccine, FDA says.

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.