Zenas BioPharma plans to have data from four trials – two under way and two starting this summer – for obexelimab, which targets CD19 and FcγRIIb, within about a year and a half.

The US Food and Drug Administration has requested additional efficacy information on the supplemental filing in the potentially large new indication.

Theradaptive, which makes a device-biologic combination product to help speed bone healing, recently got authorization to start human trials from the US FDA. Medtech Insight spoke to CEO Luis Alvarez about the company’s past, present and future.

This week, the FDA extended a comment period on digital health tools to detect diabetes; Theradaptive launched a trial of its spinal fusion device; and devices from Hologic and GE Healthcare won FDA clearance.