Page 2 - Breakthrough Designation News Today

From an update on Prism for PTSD to the efficacy of home-use transcranial direct current stimulation for MDD, here are highlights from the week in Psychiatric Times.

Dhruva explains how physicians reported a lack of understanding when it comes to the FDA approval process, especially regarding expedited approval pathways.

The FDA approval of Edwards Lifesciences EVOQUE tricuspid valve replacement system for treatment of symptomatic severe tricuspid regurgitation is the first of its kind for a transcatheter therapy.

Biomimetic Innovations' injectable bone filler has been granted Breakthrough Designation by the FDA, giving a boost to its development.

FDA grants global Medical Device company Biomimetic Innovations ‘Breakthrough Device’ designation for OsStic® Synthetic Injectable Structural...

Plans to have ten or more potentially registrational trials by the end of 2024 Preparing to be commercial-ready by the end of 2025 Ended 2023 with approximately €17.5 billion in cash, cash...

PRINCETON, N.J., Dec. 28, 2023 -- CytoSorbents Corporation , a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its...

CytoSorbents Corporation announced an update on the initial data analysis of primary safety and effectiveness endpoints and the final independent Data and Safety Monitoring Board analysis for the...

Designation follows interim Phase 1 PRISM clinical data for 4D-150 that demonstrated an encouraging safety, tolerability and clinical activity profile in patients with wet age-related macular...

Theralase Technologies Inc (TSX-V:TLT, OTCQB:TLTFF) is aiming to leverage positive study data during 3Q into a Breakthrough Therapy designation from the US...