Page 15 - Urovant Sciences News Today : Breaking News, Live Updates & Top Stories | Vimarsana

FDA approves Gemtesa for overactive bladder ADD TOPIC TO EMAIL ALERTS Receive an email when new articles are posted on Please provide your email address to receive an email when new articles are posted on . Subscribe ADDED TO EMAIL ALERTS You've successfully added to your alerts. You will receive an email when new content is published. Back to Healio We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio The FDA recently approved a new drug appli...

Press release content from Business Wire. The AP news staff was not involved in its creation. Urovant Sciences Announces U.S. FDA Approval of GEMTESA® (vibegron) 75 mg Tablets for the Treatment of Patients with Overactive Bladder (OAB) December 23, 2020 GMT IRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Dec 23, 2020-- Urovant Sciences (Nasdaq: UROV) announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for once-daily 75 mg GEMTESA® (vibegron), a beta-3 adrenergic receptor (β3) agonist, for the treatment of overactive bladder (OA...

Posted on 16366 Urovant Sciences (Nasdaq: UROV) announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for once-daily 75 mg GEMTESA® (vibegron), a beta-3 adrenergic receptor (β3) agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults. This approval marks the first new oral branded OAB medication approved by the FDA since 2012, and it is the first product approval for Urovant Sciences. �...

Dec 23, 2020 21:05 UTC Urovant Sciences Announces U.S. FDA Approval of GEMTESA® (vibegron) 75 mg Tablets for the Treatment of Patients with Overactive Bladder (OAB) IRVINE, Calif. & BASEL, Switzerland--(Business Wire)--Urovant Sciences (Nasdaq: UROV) announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for once-daily 75 mg GEMTESA® (vibegron), a beta-3 adrenergic receptor (β3) agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults. This approv...

On May 14, the company presented data from the vibegron EMPOWUR 52-week extension study and data by age groups from the 12-week placebo-controlled EMPOWUR study at the 2020 American Urological Association Annual Meeting. The data supported the potential benefits of the drug for OAB in patients with urge urinary incontinence (UUI), urgency, and urinary frequency. The drug is a once-daily, beta-3 adrenergic agonist. David Staskin, principal investigator of EMPOWUR and a urologist with St. Elizabeth’s Medical Center and associate professor of Urology at Tufts University School of Medicine, sai...