The application includes data from a phase 3 trial that evaluated a booster dose of Comirnaty in 306 adult participants 18 to 55 years of age who were previously vaccinated with a 2-dose primary regimen.
The recalled lot of Lidocaine HCl Topical Solution 4% (40mg/mL) was distributed at the wholesale and retail distribution levels.
Study authors analyzed data from 10,541 hospitalized patients with active COVID-19 disease to evaluate the relationship between the use of statins and COVID-19 outcomes.
Kloxxado is an opioid antagonist that delivers 8mg of naloxone hydrochloride per spray into the nasal cavity.
The phase 3 trial evaluated dupilumab, in addition to standard of care low potency topical corticosteroids, in 162 patients aged 6 months to 5 years with uncontrolled moderate to severe atopic dermatitis.
The MDOs were issued to approximately 55,000 flavored ENDS products from JD Nova Group LLC, Great American Vapes, and Vapor Salon and included favors such as Apple Crumble, Dr. Cola and Cinnamon Toast Cereal.
The application is supported by data from the phase 2 IMCgp100-202 trial that assessed tebentafusp in 378 HLA-A*02:01-positive adults with previously untreated metastatic uveal melanoma.
LYN-014 is an investigational oral, once-weekly, ultra-long-acting, extended-release levomethadone capsule to treat opioid use disorder.
Lebrikizumab is a novel humanized monoclonal antibody that selectively inhibits IL-13.
Tapinarof is an investigational, novel, aryl hydrocarbon receptor modulating agent designed as a once-daily, steroid-free topical cream.
