The new approval was based on data from an open-label, single-arm phase 2/3 study that evaluated the efficacy, safety and pharmacokinetics of Biktarvy in 22 virologically suppressed pediatric patients.
Tyrvaya contains varenicline, a highly selective nicotinic acetylcholine agonist.
The approval was based on data from the phase 3 IMpower010 study.
The expanded approval was based on data from a phase 3 study that compared Flucelvax Quadrivalent to a US-licensed comparator quadrivalent influenza vaccine.
The approval was based on data from the phase 3 heiGHt trial, which compared Skytrofa to somatropin in 161 treatment-naïve, prepubertal patients with growth hormone deficiency.
Cudetaxestat is a noncompetitive, reversible inhibitor of autotaxin.
The BLA submission is supported by data from two phase 3 trials that included more than 6000 patients.
N-nitroso-irbesartan is a probable human carcinogen based on results from laboratory tests.
The approval was based on data from the phase 3 KEYNOTE-826 trial.
The approval is based on data from the phase 3 monarchE trial.
