Tag Archive for: us

Hansa Biopharma’s Biologics License Application (BLA) for imlifidase accepted by the FDA

Lund, Sweden, 18 February 2026. Hansa Biopharma AB, (“Hansa” or “the Company”), (Nasdaq Stockholm: HNSA), today announced that its Biologics License Application (BLA) for imlifidase has been accepted by the U.S. Food and Drug Administration (FDA). FDA’s filing review was completed on day 60 which is meant to verify that the submission is substantially complete […]

ViCentra Strengthens Leadership Team to Accelerate Growth

Karen Baxter, former VP & GM at Dexcom with deep expertise in diabetes device commercialization across Europe, joins as SVP Sales, Europe Jay Little, leader from Medtronic Diabetes, appointed VP Strategy & Business Development Team expansion will drive growth strategy, market development, and partnerships for scalable expansion to accelerate Kaleido’s growth across European markets Utrecht, […]

Xeltis receives IDE approval from FDA for initiation of US pivotal trial for aXessTM, its restorative vascular access conduit

aXess is a restorative arteriovenous dialysis conduit which allows vascular access for hemodialysis through the creation of a new, permanent, living vessel EINDHOVEN, The Netherlands, 13 June 2024 – Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, announces that it has gained approval from the US […]

Biocomposites announces two new Phase II clinical trials of STIMULAN VG – a calcium matrix antibiotic carrier mixed with vancomycin and gentamicin – in the U.S.

BLADE-VG2 trial will evaluate the safety and efficacy of STIMULAN VG to treat diabetic foot osteomyelitis BLADE-OPU2 will evaluate the safety and efficacy of STIMULAN VG to treat stage IV pressure ulcers Keele, UK, 7 February 2024 – Biocomposites, an international medical devices company that engineers, manufactures and markets world leading products for use in infection management […]