The U.S. Food and Drug Administration approved the first non-radioactive, dual-tracer for sentinel lymph node biopsy.
The U.S. FDA approved Senseonics Holdings’ Premarket Approval application to market the company’s Eversense Continuous Glucose Monitoring System to people with diabetes.
DyAnsys Inc. announced that the U.S. Food and Drug Administration cleared the company’s auricular neurostimulation device, Drug Relief, to be used as an aid to reduce the symptoms of opioid withdrawal without narcotics.
Five Prime Therapeutics announced a collaboration with Roche to develop immunohistochemistry companion diagnostic assays for use with the clinical-stage biotechnology company’s first-in-class investigational drug candidates: the anti-FGFR2b antibody bemarituzumab (also known as FPA144) and the a B7-H4 antibody FPA150.
GlaxoSmithKline plc and Innoviva Inc. announced the submission of a regulatory application to the Japanese Ministry of Health, Labour and Welfare for once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25 mcg) under the proposed brand name of Trelegy Ellipta for the treatment of adults with chronic obstructive pulmonary disease. This is the first regulatory filing to be made in Japan for a triple COPD therapy in a single inhaler.
Foundation Medicine Inc. announced a collaboration with Merck & Co. to develop companion diagnostic tests for use with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy and the first approved immunotherapy for microsatellite instability high or mismatch repair deficient solid tumors.
Abbott received approval from the U.S. Food and Drug Administration for XIENCE Sierra, the newest generation of the gold-standard XIENCE everolimus-eluting coronary stent system.
The U.S. Food and Drug Administration permitted marketing of the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes.
W2O announced the appointment of Rita Glaze as Practice Leader of Value, Pricing and Market Access to strengthen its healthcare commercialization offering.
Anika Therapeutics Inc. announced that its HA-based bone void filler received 510(k) clearance from the U.S. FDA and is indicated for filling bone voids or defects of the skeletal system, which are not intrinsic to the stability of the bone, created during surgery or resulting from traumatic injury.