July 2021 FDA drug approvals include treatments for T2D in adolescents, trichomoniasis, and acne vulgaris, as well as a vaccine for pneumococcal diseases.
Drug previously approved for treatment of complicated intra-abdominal infections, UTIs.
In randomized trial, drug demonstrated statistically significant improvement in progression-free survival.
Ruzurgi previously approved for treatment in adults with Lambert-Eaton myasthenic syndrome.
The expanded approval was based on safety and efficacy data from a confirmatory Phase 3 randomized, double-blind, placebo-controlled multicenter study evaluating Osphena in patients with moderate to severe vaginal dryness.
Tosymra is an intranasal spray containing sumatriptan 10mg, a selective 5-HT1B/1D receptor agonist.
The approval was based on data from the KEYNOTE-224 study, a single-arm trial in patients with HCC who had disease progression on or after sorafenib or were intolerant to sorafenib; had measurable disease; and Child-Pugh class A liver impairment.