BioSpace News Archive

The U.S. Food and Drug Administration today approved the Eversense Continuous Glucose Monitoring (CGM) system for use in people 18 years of age and older with diabetes. This is the first FDA-approved CGM system to include a fully implantable sensor to detect glucose, which can be worn for up to 90 days.

June 21, 2018 20:05 UTC Revance Doses First Patient in ASPEN Phase 3 Clinical Program of RT002 Injectable for the Treatment of Cervical Dystonia - RT002 Injectable has potential to be first long-acting neuromodulator for treatment of a debilitating involuntary muscle movement disorder - NEWARK, Calif.--( BUSINESS WIRE )-- Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company developing neuromodulators for use in tre

AngioDynamics today announced that it will report financial results for the fourth quarter and fiscal year 2018 before the market open on Wednesday, July 11, 2018.

iX Biopharma Ltd. is pleased to announce the approval by Therapeutic Goods Administration (“TGA”), the regulatory authority in Australia, for WAFESIL.

Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) for the treatment of first-line advanced non-small cell lung cancer (NSCLC) in patients with tumor mutational burden (TMB) ≥10 mutations per megabase (mut/Mb). The target FDA action date is February 20, 2019.