FDA News and Regulatory Updates

If EUA is granted, the Novavax COVID-19 vaccine would be the first protein-based COVID-19 vaccine available in the US.

The Abbott FreeStyle Libre 3 is the smallest, thinnest, and most accurate 14-day CGM with a 7.9% MARD, the company says.

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.

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.

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.