Vibegron Cuts Daily Urge Urinary Incontinence Episodes, Micturitions in OAB Study
Urovant Sciences announced topline data from the phase 3 EMPOWUR trial which evaluated vibegron in adult patients with symptoms of overactive bladder.
All articles by Da Hee Han, PharmD
Osphena Approved for Moderate to Severe Vaginal Dryness Due to Menopause
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.
FDA Fast-Tracks Novel Oral Antibiotic for C. difficile Infection
The investigational drug is currently in Phase 1 development, with completion expected in the second quarter of 2019.
FDA-Approved Wearable Blood Pressure Monitor Now Available
HeartGuide is designed as a wrist watch that uses the oscillometric cuff method, the standard for medical-grade personal blood pressure measurement.
Parkinson Disease Treatment Soon to Be Discontinued
Requip and Requip XL are non-ergot dopamine agonists indicated for the treatment of Parkinson disease.
Lynparza OK’d as First-Line Maintenance of BRCA-Mutated Advanced Ovarian CA
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.
FDA to Review Treatment for Jet Lag Disorder
In the Phase 3 JET8 study (N=318), patients underwent a circadian challenge of 8 hours in advance to their usual bedtime.
ASH: New Venous Thromboembolism Clinical Practice Guideline
The guidelines were developed by over 100 experts, including hematologists, patient representatives, and other specialists.
Oral Therapy for Suicidal Bipolar Depression Gets Breakthrough Designation
NRX-101 combines D-cycloserine (DCS), an N-methyl-D-aspartate (NMDA) receptor antagonist, and lurasidone, a D2/5-HT2a receptor antagonist.
Women Fed Soy Formula as Infants More Likely to Experience Menstrual Pain
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).
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