FDA Clears Abbott’s Multiplex Test for Sexually Transmitted Infections
The Alinity m STI Assay uses in vitro RT-PCR technology with high sensitivity to detect and differentiate STIs from symptomatic and asymptomatic individuals.
The Alinity m STI Assay uses in vitro RT-PCR technology with high sensitivity to detect and differentiate STIs from symptomatic and asymptomatic individuals.
The sBLA was supported by data from the phase 3 TOPAZ-1 trial.
The approval was based on data from a phase 3 study that compared Voquezna Triple and Dual Pak with lansoprazole plus amoxicillin and clarithromycin.
In 2 minutes, the portable ATUSA system automatically scans the entire breast volume and provides 3D visualization of the breast tissue.
GPH101 is an investigational gene-edited autologous hematopoietic stem cell therapy designed to correct the mutation in the beta-globin gene and potentially curing the disease.
The sNDA is supported by data from the phase 3 ARASENS trial, which included1306 patients with mHSPC.
UB-311 is an immunotherapeutic vaccine candidate that targets toxic forms of aggregated amyloid beta in the brain.
The approval was based on data from a phase 3 trial that assessed Qelbree in adults 18 to 65 years of age with ADHD.
Daridorexant is a dual orexin receptor antagonist designed to suppress wake drive by blocking the binding of wake-promoting neuropeptides orexin A and orexin B to its receptors.
The approval was based on data from a phase 3 study that compared Cuvrior with penicillamine in 53 adults with Wilson disease.