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.
The investigational drug is currently in Phase 1 development, with completion expected in the second quarter of 2019.
HeartGuide is designed as a wrist watch that uses the oscillometric cuff method, the standard for medical-grade personal blood pressure measurement.
Requip and Requip XL are non-ergot dopamine agonists indicated for the treatment of Parkinson disease.
Lynparza, a poly (ADP-ribose) polymerase (PARP) inhibitor is already approved to treat certain breast, epithelial ovarian, fallopian tube or primary peritoneal cancers based on an FDA-approved companion diagnostic.
In the Phase 3 JET8 study (N=318), patients underwent a circadian challenge of 8 hours in advance to their usual bedtime.
The guidelines were developed by over 100 experts, including hematologists, patient representatives, and other specialists.
NRX-101 combines D-cycloserine (DCS), an N-methyl-D-aspartate (NMDA) receptor antagonist, and lurasidone, a D2/5-HT2a receptor antagonist.
Researchers at the National Institute of Environmental Health Sciences (NIEHS), Vanderbilt University Medical Center, and the Henry Ford Health System analyzed patient data from African-American women aged 23 to 35 years (N=1553) who were participating in the NIEHS Study of Environment, Lifestyle, and Fibroids (SELF).
Approval from the Food and Drug Administration (FDA) was supported by the Phase 3 Replenish trial which evaluated the safety and efficacy of Bijuva in generally healthy, postmenopausal women with a uterus for the treatment of moderate to severe hot flashes.
